PHR1016

Supelco

Chlorpheniramine Maleate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
(±)-Chlorpheniramine maleate salt
Empirical Formula (Hill Notation):
C16H19ClN2 · C4H4O4
CAS Number:
Molecular Weight:
390.86
EC Number:
MDL number:
PubChem Substance ID:
NACRES:
NA.24
Pricing and availability is not currently available.

Quality Level

grade

certified reference material
pharmaceutical secondary standard

form

neat

CofA

current certificate can be downloaded

application(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

130-135 °C (lit.)

Featured Industry

Pharmaceutical (small molecule)

format

neat

pharmacopeia traceability

traceable to BP 81
traceable to PhEur C1800000
traceable to USP 1123000

SMILES string

CN(C)CCC(C1=CC=C(Cl)C=C1)C2=NC=CC=C2.O=C(/C=C\C(O)=O)O

InChI

1S/C16H19ClN2.C4H4O4/c1-19(2)12-10-15(16-5-3-4-11-18-16)13-6-8-14(17)9-7-13;5-3(6)1-2-4(7)8/h3-9,11,15H,10,12H2,1-2H3;1-2H,(H,5,6)(H,7,8)/b;2-1-

InChI key

DBAKFASWICGISY-BTJKTKAUSA-N

Gene Information

human ... HRH1(3269)

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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.
Chlorpheniramine Maleate is an H1-receptor antagonist drug grouped under the class of antihistaminic compounds.

Application

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.
Chlorpheniramine Maleate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various chromatography techniques.

Biochem/physiol Actions

H1 Histamine receptor antagonist.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) 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 LRAC0771 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Precautionary Statements

RIDADR

NONH for all modes of transport

WGK Germany

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis
Certificate of Origin
New approaches with two cyano columns to the separation of acetaminophen, phenylephrine, chlorpheniramine and related compounds
Olmo B, et al.
Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 817(2), 159-165 (2005)
Normal-phase LC method for simultaneous analysis of pseudophedrine hydrochloride, dextromethorphan hydrobromide, chlorpheniramine maleate, and paracetamol in tablet formulations
Al-Rimawi F
Saudi Pharmaceutical Journal : SPJ : The Official Publication of the Saudi Pharmaceutical Society, 18(2), 103-106 (2010)
Poly (ethyleneglycol) column for the determination of acetaminophen, phenylephrine and chlorpheniramine in pharmaceutical formulations
Garcia A, et al.
Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 785(2), 237-243 (2003)
CE versus HPLC for the dissolution test in a pharmaceutical formulation containing acetaminophen, phenylephrine and chlorpheniramine
Marin A and Barbas C
Journal of Pharmaceutical and Biomedical Analysis, 35(4), 769-777 (2004)
Validation of a HPLC quantification of acetaminophen, phenylephrine and chlorpheniramine in pharmaceutical formulations: capsules and sachets.
Marin A, et al.
Journal of Pharmaceutical and Biomedical Analysis, 29(4), 701-714 (2002)

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