Glycopyrronium Bromide EP/BP (Glycopyrrolate)
from Medex UK
GLYCOPYRRONIUM BROMIDE EP/BP/USP
EU GMP / CEP / COS / DMF / API
Information Sheet
Medex UK is the leading UK & worldwide distributor of GMP/CEP/COS/DMF quality
Glycopyrronium Bromide EP/BP (Glycopyrrolate).
This High Quality API is supplied with all necessary EU approvals for use in Medicinal
preparations within EU.
Advantages
 EU & WHO GMP Good Manufacturing Practice Certifications
 EU CEP/COS EDQM Certification
 DMF Drug Master File
 Very competitive pricing
 Conformity to all major quality requirements of European, US & British
Pharmacopoeias
 Low level of impurities and high purity
 Efficient delivery times
 Various pack sizes
Product Categories & Applications
 Anaesthesia
 Treating Peptic Ulcers
 COPD (Chronic Obstructive Pulmonary Disease) & Asthma
 Muscle relaxation
 Hiperhidrosis
 Powder/Solution for Iontophoresis
Medex UK – Unit 1, Woolleys Farm, Welford Road, Naseby, Northamptonshire, United Kingdom, NN6 6DF
Tel. +44 (0)1858 575 065 Fax. +44 (0)1858 575 095
Email: [email protected]
Web. www.medexuk.co.uk
PRODUCT SPECIFICATION
GLYCOPYRRONIUM BROMIDE EP/BP/USP
PRODUCT
Glycopyrronium Bromide EP/BP
(Glycopyrrolate)
CAS NO [596-51-0]
CHARACTERISTICS
White or almost white, crystalline powder.
Freely soluble in water, soluble in ethanol (96%),
very slightly soluble in methylene chloride.
TEST
Content
Identification
Appearance of solution
Related substances
Acidity or alkalinity
Impurity N
Loss on drying
Sulfated ash
STORAGE
SPECIFICATION
99.0% – 101.0% (dried basis)
Complies with EP/BP tests
Solution S is clear and colourless
Impurity I
Maximum 0.3%
Impurity E
Maximum 0.2%
Unspecified impurities
Maximum 0.1%
Total impurities
Maximum 0.5%
Complies with EP/BP test. The solution is red or orange.
Maximum 0.2%
Maximum 0.5%
Maximum 0.1%
Store in a well-closed airtight containers in a cool, dark place.
PRODUCT NAMED ABOVE COMPLIES WITH THE SPECIFICATION OF EP/BP.
For more information please contact our sales team on:
Email:
[email protected]
Tel:
+44 01858 575 065
Fax:
+44 01858 575 095
Web Enquiry:
SEND ENQUIRY
Medex UK – Unit 1, Woolleys Farm, Welford Road, Naseby, Northamptonshire, United Kingdom, NN6 6DF
Tel. +44 (0)1858 575 065 Fax. +44 (0)1858 575 095
Email: [email protected]
Web. www.medexuk.co.uk
GLYCOPYRRONIUM BROMIDE EP/BP/USP
PRODUCT SPECIFICATION
PRODUCT
Glycopyrrolate USP
CAS NO [596-51-0]
CHARACTERISTICS
TEST
Content
Identification
Residue on ignition
Ordinary Impurities
Melting Range
Loss on drying
STORAGE
White crystalline powder.
SPECIFICATION
98.0% – 100.5% (dried basis)
Complies with USP tests
Maximum 0.3%
Single impurity
Maximum 0.5%
Total impurities
Maximum 2.0%
o
o
o
193 to 198 C, range < 2
Maximum 0.5%
Store in a well-closed airtight containers in a cool, dark place.
PRODUCT NAMED ABOVE COMPLIES WITH THE SPECIFICATION OF USP.
For more information please contact our sales team on:
Email:
[email protected]
Tel:
+44 01858 575 065
Fax:
+44 01858 575 095
Web Enquiry:
SEND ENQUIRY
Medex UK – Unit 1, Woolleys Farm, Welford Road, Naseby, Northamptonshire, United Kingdom, NN6 6DF
Tel. +44 (0)1858 575 065 Fax. +44 (0)1858 575 095
Email: [email protected]
Web. www.medexuk.co.uk

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