Diphenoxylate Hydrochloride Usp Ip Bp Ep Manufacturer - Indiaprice: contact company for price
Product Name Diphenoxylate Hydrochloride USP CAS No: 3810- 80- 8
Batch No: DIP/ 030313 A. R. No 13/ FP/ DIP/ 0303
Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13
Batch Quantity 165 kg Date of Retest Jan- 2016
Sr. No Test Results Acceptance Criteria
3. Identification Complies a) By HPLC: Retention time of the principle peak in the chromatogram obtained with sample solution should match with that of the principle peak in chromatogram obtained with standard solution.
Complies b) Chloride: A saturated solution meets the requirements.
4. Loss on drying 0.31% NMT 0.5%
5. Assay 99.73% 98.0% –102.0%
6. Melting Temperature 221º 220°–226°
PRODUCT SPECIFICATIONS CONTROLLED SUBSTANCES
Effective 3/ 2014
CAS REGISTRY NO.
3810- 80- 8
White crystalline powder
IDENTIFICATION ( USP)
( A) IR: To match standard
( B) UV: A257/ A252 = 1.1 – 1.3
( C) Chloride: White curdy precipitate
MELTING RANGE ( USP)
LOSS ON DRYING ( USP)
ORDINARY IMPURITIES ( USP)
ASSAY ( C30H32N2
· HCl) ( DRIED
BASIS) ( USP)
98.0 – 102.0%
ASSAY ( DIPHENOXYLATE
HYDROCHLORIDE) ( DRIED BASIS) ( HPLC)
Normeperidine Hydrochloride: 0.50% w/ w Max
Impurity A: 0.50% w/ w Max
Diphenoxylic Acid: 0.50% w/ w Max
Unknown rel. subs. ( each) : 0.10% w/ w Max
Total rel. subs. : 1.0% w/ w Max
NO. +325: 40% Max retained
DIPHENOXYLATE is a synthetic meperidine derivative
used as adjunctive therapy in the treatment of diarrhea.
Because Diphenoxylate may be abused by taking it in
doses that are larger than prescribed, a small amount of
atropine sulphate is included. This causes unpleasant
effects if larger than normal doses are taken, and
Common Trade Name: Lomotil®
- Posted By: SWAPNROOP DRUGS AND PHARMACEUTICALS
- Phone: 912406641875
- Address: PLOT NO: 04 JALGAON ROAD, HARSOOL, AURANGABAD, India
- Website: http://www.apisupplier.com
Published date: September 7, 2015 -
- Business Description: We, at SWAPNROOP, are committed to providing affordable Drugs &
Pharmaceuticals of global quality standards to Pharma Companies all over
the world. In our warehouse facilities, approved by FDA. we supply
Pharmaceutical Finished products, Dental products and Active
We, at SWAPNROOP, are committed to providing affordable Drugs & Pharmaceuticals of global quality standards to Pharma Companies all over the world. Our warehouse facilities is approved by FDA and we are specializes in sales and marketing of Pharmaceutical Finished products, Pharmaceutical Active Ingredients (API's) and Dental products, providing a wide range of quality and affordable products to a large number of pharmaceutical companies, reputed private and government/semi government organizations/ research centers as well as universities.
We supply and market over 500 molecules and their combinations in multiple dosage forms, catering to patient needs in various therapies. These include Anti infectives, Cardiovascular, Pain management, Central Nervous System (CNS), Gastrointestinal, Respiratory, Dermatology, Orthopaedics, Nutritionals, Urology and Dental.
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