PHR1738

Bupivacaine Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): 6-(butylamino)-N-(2,6-dimethylphenyl)hexanamide (Bupivacaine Related Compound A) (Bupivacaine Impurity E)
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to Ph. Eur. Y0000089; traceable to USP 1078518
• API family: bupivacaine
• CofA: current certificate can be downloaded
• packaging: pkg of 40 mg
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C

Description

General description

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Bupivacaine and its derivatives are a category of compounds that are used as local anesthetics. Its applications consist of infiltration, nerve block, epidural, and intrathecal anesthesia.

Application

Bupivacaine may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatographic and spectrophotometric techniques.

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAA7909 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• pictograms: GHS06
• signalword: Danger
• hcodes: H301,H413
• pcodes: P273 - P301 + P310 + P330
• Hazard Classifications: Acute Tox. 3 Oral - Aquatic Chronic 4
• Storage Class: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable