Latest summary minutes (December 2013)

17 December 2013
Expert Advisory Group MC1: Medicinal Chemicals 1
BRITISH PHARMACOPOEIA COMMISSION
EXPERT ADVISORY GROUP (EAG): MEDICINAL CHEMICALS 1 (MC1)
SUMMARY MINUTES
A meeting of Expert Advisory Group (EAG): Medicinal Chemicals (MC1) was held at
151 Buckingham Palace Road, London SW1W 9SZ on Tuesday, 17th December 2013.
Present: Professor A G Davidson (Chairman), Professor D Cairns (Vice-chairman),
Dr M Ahmed, Dr J C Berridge, Mr A J Caws, Dr V Loh and Mr P Fleming.
Apologies: Mr M Broughton, Dr W J Lough and Mr D Malpas.
In attendance: Mrs M Barrett, Ms H Corns, Mr S Humphreys and Mr A Panchal.
INTRODUCTORY REMARKS
222
Welcome
The Chairman welcomed everyone to the meeting. He informed members that, due
to restructuring, Dr Holland had taken up new responsibilities within the BP
Secretariat. Members recorded their thanks for her contribution to the expert group
and wished her well in her new role.
Members welcomed Ms H Corns as the new member of the EAG: MC1 Secretariat
and Dr V Loh, a new expert, from the Licensing Division of the MHRA.
Members also welcomed Mr A Panchal and Mr S Humphreys from the BP
Laboratory.
I
MINUTES
223
The minutes of the meeting held on 3rd June 2013 were confirmed.
224
Emergency evacuation procedure
MC1 (13) 26
The emergency evacuation procedure for Buckingham Palace Road was noted.
225
MC1 (13) 27
Declaration of interests
Members had declared their interests prior to the meeting.
226
MC1 (13) 28
BP Website Development
Members were informed that the BP website was under review.
227
MC1 (13) 29
New MHRA structure
Members were given an overview of the new structure within the Medicines and
Healthcare Products Regulatory Agency (MHRA) following the merger with the
National Institute for Biological Standards and Control (NIBSC) which had
become part of the Agency in April 2013. Members were informed that the
Clinical Practice Research Datalink (CPRD) had become part of the Agency in
2012.
In September 2013 Dr Ian Hudson had succeeded Professor Sir Kent Woods as the
new Chief Executive of the MHRA. Dr Hudson had previously been the head of
the MHRA Licensing Division.
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In October 2013 Professor Kevin Taylor had been appointed as the Chairman of
the BP Commission. Professor Taylor was Head of Pharmaceutics at the School of
Pharmacy at University College, London.
228
Issues arising from the BP Commission
MC1 (13) 30
Members were provided with an update on matters recently discussed by the BP
Commission.
Inhaled Products Members were informed that the work of the Inhaled Products
Working Party had been completed and that the inhaled products policy could be
found on the BP website.
Omitted Monographs Advice had been sought on the legal status of monographs
omitted from the BP following the implementation of the Human Medicines
Regulations. The advice received was that as there had been no substantive change
in the Regulations and that the previously omitted monographs would remain in
force in perpetuity.
Good Pharmacopoeial Practices Members were informed that the BP Secretariat
was contributing to the development of WHO guidelines on Good Pharmacopoeial
Practices, particularly in relation to finished products. The work was on-going and
the BP Secretariat would keep members updated with developments that might
affect the work of the EAG.
Disregard Limits It had been agreed by the BPC that a disregard limit could be
based on a solution with a higher concentration than the limit of disregard provided
that this solution was not more than 4 times the concentration.
II
MATTERS ARISING FROM THE MINUTES
229
Matters arising
MC1 (13) 31
A list of ‘Matters Arising’ from the minutes of the meeting of EAG MC1 held in
June 2013 and those outstanding from previous meetings was circulated with the
papers for the meeting. A copy is appended (Annex 1).
230
MC1 (13) 32
Laboratory Work update
A document outlining the BP Laboratory work schedule for BP 2015 was presented for
information.
The Secretariat had recently received comments on the draft monographs for Rizatriptan
Tablets and Rizatriptan Orodispersible Tablets.
Difficulties had been encountered in the BP Laboratory when developing methods for
Terbinafine Tablets and that further work was being carried out.
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Work on the revision of Propofol Injection had been held up due to the lack of samples.
The Secretariat would endeavour to source further samples.
231
Gastro-resistant Omeprazole Capsules
MC1 (13) 33
Assay In the published BP assay method for Gastro-resistant Omeprazole Capsules the
analyst was required to grind the contents of the capsule to a fine powder before
carrying out the test. At the June 2013 meeting members were informed that a
manufacturer had requested a revision to the assay method to test the capsule contents
‘as is’ as they had observed that grinding the capsule contents before dissolution
produced low assay results.
Laboratory assessment The BP Laboratory had carried out the Assay as instructed in
the BP 2013 and had also extracted the active from the whole contents. Members
commented that the differences between the two sets of laboratory results were
statistically not significant but that the monograph would be revised for BP 2015 to
include the whole contents of the capsules. This would remove a step in the sample
preparation which could potentially produce lower assay results.
Publication The revised monograph would be published in BP 2015.
232
MC1 (13) 34
Colchicine Tablets
A manufacturer had previously provided information on the methods and data to enable
the BP Secretariat to revise the monograph for Colchicine Tablets.
Content of Colchicine The manufacturer had further reviewed batch and stability data
for their product and had agreed that the revised limits of ‘95.0% to 105.0%’ were
suitable for their product.
Identification The manufacturer had advised that they had not been able to devise an
infrared test that they were in the process of developing a UV method for identification.
The results would be circulated to members when they became available.
233
Dipyridamole Infusion
Prolonged-release Dipyridamole Capsules
MC1 (13) 35
Samples of impurities Members were informed that samples of dipyridamole ditartaric
acid ester and dipyridamole tartaric acid monoester, impurities 1 and 2 respectively,
which were required for the impurity standard BPCRS for the two monographs had been
synthesised by a contract laboratory.
Establishment of the reference material The BP Laboratory would carry out tests to
verify the structures of the two impurities and establish the impurity standard at the
earliest opportunity. The response factors for these impurities relative to Dipyridamole
would also be determined.
234
MC1 (13) 36
Fentanyl (Citrate) Injection
Identification test for Citrate At the June 2013 meeting members had queried whether
an identification test for citrate was necessary, in the monograph for Fentanyl Citrate, as
citrate had no pharmacological effect in solution. In this instance members agreed that
the test for identification of citrate would be removed from the monograph by means of
BP 2015.
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Expert Advisory Group MC1: Medicinal Chemicals 1
III
REPORTS AND CORRESPONDENCE
235
Anti-epileptics: Guidance received from the MHRA on interchangeability
MC1 (13) 37
In November 2013 guidance had been circulated by the MHRA to prescribers,
pharmacists and patients on the interchangeability of anti-epileptic drugs (AEDs). The
Committee on Human Medicines (CHM) had reviewed evidence on patients switching
between different manufacturers’ products and had concluded that, although there was
no clear evidence of harm associated with switching products, an effect on some
patients could not be ruled out. CHM had classified the various AEDs into three
categories.
Category 1: Practitioners were advised to ensure that the patient was maintained on a
specific product. This category included the AEDs Phenytoin, Carbamazepine and
Primidone for which EAG: MC1 had responsibility.
Category 2: The need to maintain a specific product would be based on clinical
judgement and consultation with the patient or carer and taking into account seizure
frequency and treatment history. This category included the AEDs Valproate,
Lamotrigine, Oxcarbazine and Topiramate for which EAG: MC1 had responsibility.
Category 3 It was unnecessary to maintain a single manufacturer’s product.
Opening statement in monographs for AEDs Members discussed whether an opening
statement on non-interchangeability should be included in any of the MC1 monographs
in the various categories. They bore in mind that the monograph for Carbamazepine
Tablets already contained the statement Carbamazepine Tablets from different
manufacturers, whilst complying with the requirements of the monograph, are not
interchangeable which had been agreed by the Pharmacy Expert Group and MC1
members in 2003.
Members agreed that a precedent had been set in the case of Carbamazepine Tablets and
a comparable statement should be included in all of the MC1-related Category 1
products - Phenytoin, Carbamazepine and Primidone.
Members had a wide-ranging discussion on Category 2 products. It was noted that it
was a clinical decision whether a specific product would be maintained for a patient.
The therapeutic window to avoid seizures was small and also the emotional and
psychological aspects would also need to be taken into account by the clinician.
The consensus was that MC1 members would not recommend an opening statement for
category 2 products as in this case the decision should be made on clinical judgement.
BP Commission MC1 Experts’ views would be forwarded to the BP Commission who
would be asked to make the decision on opening statements for the various categories.
236
MC1 (13) 38
Trihexphenidyl Tablets
The Secretariat had been informed that the quantity of powdered tablet to be used in
Identification test A was not specified in the monograph for Trihexphenidyl Tablets.
The quantity had been accidently omitted during restyling of the monograph. The
monograph had been revised to include a direction to use 20 mg of the powdered tablets.
Members agreed that the amendment would be published in the BP 2015.
It was noted that chloroform was used within Identification test A and that this would be
reviewed in line with BPC policy to replace chloroform where possible. Members
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agreed that a suitable replacement would be investigated.
237
MC1 (13) 39
Tenoxicam for Injection
A manufacturer had asked for the limits for Tenoxicam, in the BP monograph for
Tenoxicam for Injection, to be reviewed. The current monograph had skewed limits of
104.5% to 115.5%.
Members noted that the monograph for Tenoxicam Injection instructed the user to dilute
the lyophilised powder with the requisite amount of water for injections. It was usual
practice for the water for injections at the correct volume to be supplied in a sealed vial
along with the vial of lyophilisate. It was stated that the overage was supplied so that
when the solution was prepared there was sufficient of the solution present for the
correct volume to be removed easily from the vial.
Members agreed that the current limits would be retained. The manufacturer to be
informed that no changes would be made to the published limits.
238
MC1 (13) 40
Domperidone (Maleate) Tablets
A manufacturer had requested that a statement be included in the Related substances
test for Domperidone Tablets to disregard the peak due to Maleic Acid as the inclusion
of the peak area in the calculation of impurities present could give falsely high results.
Members agreed that a statement would be included in the related substances test
similar to that of the Ph. Eur. monograph for the active substance – disregard any peak
due to maleic acid at the beginning of the chromatogram. The revised monograph
would be published in BP 2015.
239
MC1 (13) 41
Methotrexate Injection
Members were informed that the Pharmacy Expert Advisory Group: EAG PCY had
requested the removal of the labelling statement regarding preservatives from the
monograph for Methotrexate Injection. The Labelling statement instructed the user not
to use the injection for intrathecal administration when preservatives were present but
there were currently no licensed products marketed in the UK containing preservatives.
In addition, EAG PCY had stated that negative Labelling statements should not be used
as they could increase the risk of administration via an incorrect route. Members agreed
that the labelling statement would be removed from the monograph in the BP 2015.
IV
REVISION OF MONOGRAPHS
240
Carbimazole Tablets
MC1 (13) 42
Thiamazole and other related substances A request had been submitted by a
manufacturer to revise the test for Thiamazole and other related substances in the
monograph for Carbimzole Tablets. Members reviewed the report and agreed to that
the revisions proposed by the manufacturer would be adopted.
241
Aspirin Preparations
Dispersible Aspirin Tablets
Effervescent Soluble Aspirin Tablets
Aspirin and Caffeine Tablets
Co-codaprin Tablets
Dispersible Co-codaprin Tablets
MC1 (13) 43
Test for Salicylic Acid At the December 2012 meeting members were informed that a
manufacturer had queried the use of water to dissolve salicylic acid in the reference
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solution when 96% ethanol was used to dissolve the sample solution. It was noted
that by definition salicylic acid is ‘slightly soluble in water’ (1g dissolving in 100 mL
to 1000 mL of solvent) and the analyst should have been able to prepare a 0.050%
w/v solution of salicylic acid in water.
Laboratory assessment The BP Laboratory had evaluated the effectiveness of water
and 96% ethanol to prepare the 0.050% w/v solution of salicylic acid. Although
salicylic acid dissolved in water with sonication and stirring, it dissolved immediately
in 96% ethanol. The laboratory recommended that the tests were revised to include
96% ethanol for the initial dissolution. Members agreed that the tests for Salicylic
Acid would be revised in BP 2015.
Replacement of chloroform with dichloromethane The BP Laboratory had also
confirmed that chloroform could be replaced by dichloromethane as the extraction
solvent.
Review of the Related substances test The Secretariat had drafted a Related
substances test for Aspirin Tablets, based on the method in the Ph. Eur. monograph
for Aspirin, to replace the test for Salicylic Acid. The BP Laboratory would assess the
draft test at the earliest opportunity and if successful the test would be assessed for
the other Aspirin preparations.
242
Cetirizine Oral Solution
Cetirizine Tablets
MC1 (13) 44
A UK manufacturer had supplied data which showed that a correction factor of 0.7
was necessary to estimate impurity A in the Related substances tests for Cetirizine
Oral Solution and Cetirizine Tablets. Both BP monographs limited each of the
impurities A, B and G at not more than 0.3%. It was noted that the Ph. Eur. Related
substances test in the monograph for the active material had been revised to include
correction factors for five impurities, impurity A 0.7; impurity C 1.9; impurity D 0.6;
impurity E 1.3 and impurity F 1.9. The tests used in the BP preparation monographs
were different to the Ph. Eur. monograph and it was not clear if impurities C, D, E
and F would be detected by this method.
Correction for unspecified impurities Members discussed the consequences of
omitting a correction figure for unspecified impurities where the related substances
method for the preparation was different to the active material.
Impurity A Members agreed that a correction figure of 0.7 for impurity A would be
included in both monographs.
Unspecified impurities Manufacturers’ data and laboratory reports would be
reviewed to see if information on the unspecified impurities C, D, E and F was
available for the BP published methods. The corrections would be included in the
monographs if the information was found.
243
MC1 (13) 45
Doxepin Capsules
The BP Laboratory had assessed the use of a capillary GC column in place of a
packed column when determining the Z isomer content in Doxepin in the reference
material. A DB-624 capillary column adequately resolved the Z and E isomers.
Members agreed that the revision would be adopted subject to the inclusion of a
resolution criterion between the E and Z isomers. The laboratory agreed to calculate a
resolution factor from laboratory data. Members requested that the inconsistent use
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of mg and g in the monograph was also amended.
It was noted that chloroform was used within Identification test A and this should be
reviewed in-line with BP policy to replace chloroform where possible. Members
agreed that this would be added to the BP Laboratory work programme.
244
MC1 (13) 46
Paracetamol Preparations
Limits for 4-chloroacetanilide and 4-aminophenol Members had agreed, at a
previous meeting, the need to harmonise the limits for 4′-chloroacetanilide
(Ph. Eur. Impurity J) and 4-aminophenol (Ph. Eur. impurity K) in BP monographs
relating to Paracetamol preparations. Members reviewed the current limits for the 19
BP Paracetamol-containing products, taking into account a draft chapter in the US
Pharmacopeial Forum <227> 4-aminophenol in acetaminophen-containing drug
products and a toxicological report received from an assessor at the MHRA.
4-chloroacetanilide 4-Chloracetanilide was a synthetic impurity of Paracetamol and
it was agreed that the Ph. Eur. Limit of not more than 10 ppm would be applied to the
preparation monographs.
4-aminophenol Members stated that if an allowance of not more than 1500 ppm had
been agreed by licensing authorities for the liquid products then it would be hard to
justify tightening the limits for the solid products.
Further information The EDQM would be asked to provide any toxicological data
received during the certification of suitability procedure (CEP) to show genotoxicity
and the UK expert on the European Pharmacopoeia group with responsibility for
Paracetamol would be asked to share the data used when the Ph. Eur. monograph was
revised to include the tighter limit for 4-aminophenol.
245
MC1 (13) 47
Fenthion BP
Assay The BP Laboratory had demonstrated that a ZB-5 capillary column was a
suitable replacement for the packed column specified in the assay method for
Fenthion. Members agreed that that the assay method would be revised to include a
capillary GC column.
Assay – use of dibutyl phthalate and chloroform The BP Laboratory had also
established that the internal standard (dibutyl phthalate) could be deleted from the
test, as this chemical was restricted by the REACH directive and also that
dichloromethane could be used as a replacement for chloroform. Members agreed
that the revisions would be adopted. A system suitability requirement to test the
reproducibility of the injections of ‘the RSD on 6 injections is not greater than 2.0%’
was covered in BP Appendix III, Chromatographic Separation Techniques.
Identification test B and C and Related substances Members discussed whether
Identification tests B and C were required in addition to the infrared test and whether
the revised capillary GC method for assay could be used to update the TLC Related
substances test. It was also noted that the content limits of 90.0% to 100.5% were
wide for an API and that the impurity limits were out of line with current VICH
guidance. Members concurred that the whole monograph would benefit from a
review. The VMD would be contacted regarding the usage of Fenthion prior to
further review of the monograph, as it was noted that this compound had been banned
from use in some countries.
(Please see Secretariat note following minute 262).
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Expert Advisory Group MC1: Medicinal Chemicals 1
246
MC1 (13) 48
Hydroxycarbamide Capsules
The BP Laboratory had contacted the Secretariat to query the different TLC
stationary phases used in the tests for Urea in the Ph. Eur. monograph for
Hydroxycarbamide and BP monograph for Hydroxycarbamide Capsules. It had been
found that the Urea test from the Ph. Eur. monograph had been assessed for the BP
monograph and its inclusion, along with a test for Hydroxylamine, had been agreed.
The amended monograph had not been published at that time. Members agreed that
the amendments would be published and to include a direction to shake the mobile
phase before using the upper layer would be included under mobile phase in the Urea
test.
247
MC1 (13) 49
Ondansetron Tablets
Assay A manufacturer had provided data to show that more consistent assay results
had been achieved when the extraction solvent, acetonitrile, used in the assay method
for Ondansetron tablets, had been replaced by a 50:50 mixture of acetonitrile and the
mobile phase. They had also claimed that it was not necessary to evaporate to a
residue before dissolving in a smaller about of solvent. The BP Laboratory had
confirmed the manufacturer’s findings. Members agreed that the test would be
revised in BP 2015 to include a 50:50 mixture of acetonitrile and mobile phase.
248
MC1 (13) 50
Mianserin Tablets
Assay The BP Laboratory had demonstrated that a HP-5 capillary column was a
suitable replacement for the packed column specified in the Assay method for
Mianserin Tablets. Members agreed that the test would be revised for BP 2015.
Related substances It was highlighted that the Related substances test in the
monograph was a TLC method and that the Ph. Eur. monograph for Mianserin
Hydrochloride used a LC method for the determination of impurities. It was agreed
that the BP Laboratory would assess the Ph. Eur. LC method for use for both the
Related substances test and Assay in the capsules monograph.
Identification It was noted that the Mianserin Capsules monograph contained 3
identification tests and that confirmation of identification by IR (Identification test A)
was normally considered sufficient as a standalone identification test. Members
discussed whether it was necessary to retain all of the identification tests and agreed
that this should be reviewed by the Secretariat.
Content Members noted that the 90.0 to 110.0% content limits for the capsules were
wider than the standard limits of 95.0 to 105%. Members agreed that manufacturers
would be asked to justify the wide limits.
249
MC1 (13) 51
Procyclidine Hydrochloride
Related substances test B The BP Laboratory had demonstrated that a DB-Wax
capillary column was suitable as a replacement for the packed column specified in the
Related substances B test in the monograph for Procyclidine Hydrochloride.
Members accepted the revision to Related substances B to include the capillary GC
column.
It was noted that Procyclidine Hydrochloride was an old product and that the
monograph would benefit from a full review. Members agreed that the monograph
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Expert Advisory Group MC1: Medicinal Chemicals 1
should be reviewed and added the laboratory work programme.
250
MC1 (13) 52
Minoxidil Scalp Application
Assessment of the revised monograph At the December 2012 meeting members had
agreed that the revised monograph for Minoxidil Scalp Application would be
published subject to comment from manufacturers. Members were informed that,
following the meeting, the revised draft monograph had been assessed by an MSc
student and it had been found to be a suitable method.
The revised monograph would be published in BP 2015.
251
MC1 (13) 53
Ranitidine Oral Solution
An error in Identification A in the monograph for Ranitidine Oral Solution had been
raised by a user of the BP. method and the consequential amendment to Identification
test. The error had been corrected by adapting the previous TLC Related substances
method and members accepted the revision of Identification A.
252
Gastro-resistant Lansoprazole Capsules
Gastro-resistant Lansoprazole Tablets
MC1 (13) 54
A manufacturer had queried the use of a Supelcosil LC-ABZ 25cm x 3mm, 5μm
column in the dissolution, assay and related substances tests in the monographs for
Gastro-resistant Lansoprazole Capsules and Gastro-resistant Lansoprazole Tablets as
the chromatogram supplied with the reference material had been run on a column
with a 4.6 mm diameter. Members were informed that the monographs would be
amended for BP 2015 to include a 4.6 mm diameter column.
253
MC1 (13) 55
Aciclovir Infusion
Aciclovir Tablets
Dispersible Aciclovir Tablets
A manufacturer of Aciclovir Infusion had highlighted that the Related substances test
in the BP monograph had a tighter limits for impurities A, G, J, K, N and P than in
the Ph. Eur. API monograph. In the Ph. Eur. Aciclovir monograph, these impurities
were limited at not more than (NMT) 0.2% but because they were not specified in the
BP monograph, the ‘any other impurities’ limit of NMT 0.1% applied. When the
Related substances tests had been revised the 0.1% limit had been applied as the
maximum daily dose was above 2g per day in-line with ICH guidance. The
Secretariat had also identified the issue in the Aciclovir Tablets and Dispersible
Aciclovir Tablets monographs.
Members discussed whether the impurities should be specified at NMT 0.2% and to
retain the unspecified impurities limit of NMT 0.1% or whether to increase the
unspecified impurities limit to NMT 0.2%. It was noted that EDQM produced
reference standards that could be used to identify the impurities, if they were
specified. Members stated that there was a low risk of increased toxicity when
increasing the limits for unspecified impurities to NMT 0.2% from NMT 0.1%. In the
absence of strong views against raising the unspecified impurities limit, it was agreed
that the monograph would be revised with any other impurities limited at 0.2%. It
was recognised that it was unusual to go against ICH guidelines, but as the maximum
daily doses were just over the 2g per day boundary given in the ICH guidelines, that
it could be justified in this case.
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V
MONOGRAPHS IN PROGRESS
254
Abacavir , Zidovudine and Lamivudine Tablets
MC1 (13) 56
The draft monograph would be included in a future BP publication, subject to
comments from manufacturers.
VI
NEW MONOGRAPHS
255
Abacavir and Lamivudine Tablets
MC1 (13) 57
The draft monograph would be included in a future BP publication, subject to
comments from manufacturers.
256
MC1 (13) 58
Cetirizine Capsules
The draft monograph would be included in a future BP publication, subject to
comments from manufacturers.
257
MC1 (13) 59
Zidovudine Infusion
The draft monograph would be included in a future BP publication, subject to
comments from manufacturers.
258
MC1 (13) 60
Loperamide Oral Solution
The draft monograph would be included in a future BP publication, subject to
comments from manufacturers.
259
MC1 (13) 61
Loperamide Tablets
The draft monograph would be included in a future BP publication, subject to
comments from manufacturers.
260
Loperamide Orodispersible Tablets
MC1 (13) 62
The draft monograph would be included in a future BP publication, subject to
comments from manufacturers.
MC1 (13) 63
VII
ANY OTHER BUSINESS
261
Members were informed that requests for revision for the monographs for
Sumatriptan Tablets and Paroxetine Tablets had been received. The Secretariat would
circulate the information to members at the earliest opportunity.
262
Date of next meeting
Wednesday, 11th June 2014
SECRETARIAT NOTES
Minute 245 Fenthion: Following the meeting the VMD had confirmed that there were no
licensed products which contained Fenthion in the UK.
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Expert Advisory Group MC1: Medicinal Chemicals 1
BRITISH PHARMACOPOEIA COMMISSION
EXPERT ADVISORY GROUP MC1: Medicinal Chemicals
2.1. MATTERS ARISING FROM PREVIOUS MEETINGS OTHER THAN THOSE
MENTIONED ON THE AGENDA
Rizatriptan Tablets
Orodispersible
Rizatriptan Tablets
The BP laboratory has received sufficient reference material from
the innovator to establish Rizatriptan Benzoate assay standard. The
lab will examine the draft infrared tests at the earliest opportunity.
Terbinafine Tablets
The BP Laboratory will assess the draft tablets monograph with a
view to harmonising with the Ph. Eur. monograph for the active at
the earliest opportunity.
Flunixin Injection
Flunixin Paste
Flunixin Tablets
(Minute 684, 674
refer)
The BP Laboratory has been asked to assess the suitability of the
Ph. Eur. method for Related substances to limit the impurities 2hydroxy nicotinic acid and 2-(6-nicotinoyloxy)nicotinic acid. The
work will be progressed at the earliest opportunity.
Dihydrocodeine
Injection
Dihydrocodeine
Tablets
The BP Laboratory was asked to assess the suitability of the revised
draft method for Related substances and Assay in order to advise on
suitability for purpose. The results of the analysis will be presented
to this EAG at the earliest opportunity.
Metformin Tablets
The BP Laboratory will assess the draft revised Related substances
test and Assay at the earliest opportunity.
Propofol Injection –
test for Lysolecithin
The BP Laboratory will reassess the robustness of the lysolecithin
test method at the earliest opportunity.
Brompheniramine
Tablets
The BP Laboratory will assess the suitability of the draft revised
Related substances test method.
11

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