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PHR1016

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Chlorpheniramine Maleate

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
(±)-Chlorpheniramine maleate salt
Empirical Formula (Hill Notation):
C16H19ClN2 · C4H4O4
CAS Number:
113-92-8
Molecular Weight:
390.86
EC Number:
204-037-5
MDL number:
MFCD00069225
UNSPSC Code:
41116107
PubChem Substance ID:
329823047
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to BP 81
traceable to Ph. Eur. C1800000
traceable to USP 1123000

API family

chlorpheniramine

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

130-135 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

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

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

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.

Recommended products

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

related product

Product No.
Description
Pricing

1123000

Chlorpheniramine maleate, United States Pharmacopeia (USP) Reference Standard

C1800000

Chlorphenamine maleate, European Pharmacopoeia (EP) Reference Standard

Y0000436

Chlorphenamine impurity A, European Pharmacopoeia (EP) Reference Standard

Y0000437

Chlorphenamine impurity C, European Pharmacopoeia (EP) Reference Standard

1123135

Chlorpheniramine Related Compound B, United States Pharmacopeia (USP) Reference Standard

1123146

Chlorpheniramine Related Compound C, United States Pharmacopeia (USP) Reference Standard

38595

α-(4-Chlorophenyl)-α-[2-(dimethylamino)ethyl]-2-pyridineacetonitrile hydrochloride, pharmaceutical impurity standard

PHR1647

Chlorpheniramine Related Compound B, Pharmaceutical Secondary Standard; Certified Reference Material

PHR1688

Chlorpheniramine Related Compound C, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2004

Chlorpheniramine Impurity A, Pharmaceutical Secondary Standard; Certified Reference Material

BP081

Chlorphenamine maleate, British Pharmacopoeia (BP) Reference Standard

PHR2103

Chlorphenamine Impurity D, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2104

2-(4-Chlorophenyl)-4-dimethylaminobutyronitrile hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2105

Chlorphenamine N-Oxide Maleate, Pharmaceutical Secondary Standard; Certified Reference Material

Pictograms

Exclamation mark
GHS07

Signal Word

Warning

Hazard Statements

H302

Precautionary Statements

P301 + P312 + P330

Hazard Classifications

Acute Tox. 4 Oral

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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)
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)
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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