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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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