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Key Documents

PHR1738

Supelco

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)

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About This Item

UNSPSC Code:
41116107
NACRES:
NA.24

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

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.

Pictograms

Skull and crossbones
GHS06

Signal Word

Danger

Hazard Statements

H301,H413

Precautionary Statements

P273 - P301 + P310 + P330

Hazard Classifications

Acute Tox. 3 Oral - Aquatic Chronic 4

Storage Class Code

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
LRAD7806
LRAC4964
LRAA7909

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Protein synthesis in bupivacaine (Marcaine)-treated, regenerating skeletal muscle
Jones GH
Muscle and Nerve, 5(4), 281-290 (1982)
Determination of tramadol, metamizole, ropivacaine, and bupivacaine in analgesic mixture samples by HPLC with DAD detection
Salmeron-Garcia A, et al.
Journal of Chromatographic Science, 47(3), 231237-231237 (2009)
Bupivacaine decreases cell viability and matrix protein synthesis in an intervertebral disc organ model system
Wang D, et al.
The Spine Journal : Official Journal of the North American Spine Society, 11(2), 139-146 (2011)
Quantitative mass spectrometric analysis of ropivacaine and bupivacaine in authentic, pharmaceutical and spiked human plasma without chromatographic separation
Salama NN and Wang S
Analytical Chemistry Insights, 4(3), ACI-S2564 (2009)

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