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1709007

USP

Vancomycin hydrochloride

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

Vancomycin monohydrochloride

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About This Item

Empirical Formula (Hill Notation):
C66H75Cl2N9O24 · HCl
Molecular Weight:
1485.71
NACRES:
NA.24
UNSPSC Code:
41116107

grade

pharmaceutical primary standard

API family

vancomycin

form

solid

manufacturer/tradename

USP

application(s)

USP Biologics
pharmaceutical (small molecule)

format

neat

storage temp.

−20°C

General description

Vancomycin hydrochloride is a glycopeptide antibiotic effective against Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). It inhibits cell wall biosynthesis by binding to D-Ala-D-Ala termini of cell wall precursors. The USP standard provides a validated benchmark for microbiological assays and chromatographic identification techniques.

The USP biologics antibiotics category includes a wide range of antimicrobial agents that are essential in treating bacterial infections. These antibiotics are derived from various natural sources or synthesized to combat specific pathogens effectively. The USP provides comprehensive standards, reference materials, and analytical procedures to ensure the identity, quality, purity, and consistency of antibiotic therapeutics throughout their lifecycle.

The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.

Application

Vancomycin hydrochloride USP reference standard, intended for use in specified quality tests and assays as specified in the USP compendia. Also, for use with USP monographs such as:
  • Vancomycin Hydrochloride Capsules
  • Vancomycin Hydrochloride for Injection
  • Vancomycin Hydrochloride for Oral Solution
  • Vancomycin Injection
  • Vancomycin

Packaging

4 vials, each vial contains 99,300 mcg of vancomycin activity

Other Notes

Sales restrictions may apply.
This product is part of the USP Biologics program.

pictograms

Health hazard

signalword

Danger

hcodes

Hazard Classifications

Resp. Sens. 1 - Skin Sens. 1

Storage Class

11 - Combustible Solids

flash_point_f

Not applicable

flash_point_c

Not applicable


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Certificates of Analysis (COA)

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Vancomycin Hydrochloride for Injection
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 35(4), 4588-4588 (2020)
Vancomycin
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 44(5), 4583-4583 (2020)
Vancomycin Injection
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 27(4), 4585-4585 (2022)
Vancomycin Hydrochloride
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 35(4), 4586-4586 (2020)
Vancomycin Hydrochloride for Oral Solution
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 30(1), 4590-4590 (2013)

Related Content

Objednejte si ze široké nabídky vysoce charakterizovaných primárních referenčních standardních materiálů pro použití s monografiemi USP-NF pro testování léčivých látek a lékových forem, farmaceutických pomocných látek, složek potravin a doplňků stravy.

Order from a broad range of highly characterized primary reference standard materials to use with USP-NF monographs for the testing of drug substances & dosage forms, pharmaceutical excipients, food ingredients and dietary supplements.

Global Trade Item Number

SKUGTIN
1709007-4VL04061838750570

Questions

1–2 of 2 Questions  
  1. How can I determine the shelf life / expiration / retest date of this product?

    1 answer
    1. If this product has an expiration or retest date, it will be shown on the Certificate of Analysis (COA, CofA). If there is no retest or expiration date listed on the product's COA, we do not have suitable stability data to determine a shelf life. For these products, the only date on the COA will be the release date; a retest, expiration, or use-by-date will not be displayed.
      For all products, we recommend handling per defined conditions as printed in our product literature and website product descriptions. We recommend that products should be routinely inspected by customers to ensure they perform as expected.
      For products without retest or expiration dates, our standard warranty of 1 year from the date of shipment is applicable.
      For more information, please refer to the Product Dating Information document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/418/501/product-dating-information-06-25-mk.pdf

      Helpful?

  2. How is shipping temperature determined? And how is it related to the product storage temperature?

    1 answer
    1. Products may be shipped at a different temperature than the recommended long-term storage temperature. If the product quality is sensitive to short-term exposure to conditions other than the recommended long-term storage, it will be shipped on wet or dry-ice. If the product quality is NOT affected by short-term exposure to conditions other than the recommended long-term storage, it will be shipped at ambient temperature. As shipping routes are configured for minimum transit times, shipping at ambient temperature helps control shipping costs for our customers. For more information, please refer to the Storage and Transport Conditions document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/316/622/storage-transport-conditions-mk.pdf

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