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Diphenoxylate Hydrochloride Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

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

1. Appearance

2. Solubility

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

FORMULA

C30H32N2

O2

· HCl

MOLECULAR WEIGHT

489.06

APPEARANCE

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)

220o

- 226o

C

LOSS ON DRYING ( USP)

0.5% Max

ORDINARY IMPURITIES ( USP)

1.0% Max

ASSAY ( C30H32N2

· HCl) ( DRIED

BASIS) ( USP)

98.0 – 102.0%

ASSAY ( DIPHENOXYLATE

HYDROCHLORIDE) ( DRIED BASIS) ( HPLC)

RELATED SUBSTANCES

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

SIEVE TEST

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

discourages abuse.

Common Trade Name: Lomotil®


Company Contact:


  • Phone: 912406641875

  • Address: PLOT NO: 04 JALGAON ROAD, HARSOOL, AURANGABAD, India

  • Email: Email


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

    Pharmaceutical Ingredients.

    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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