PHR1467

Promethazine Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Promethazine hydrochloride, 10-[2-(Dimethylamino)propyl]phenothiazine hydrochloride
• Empirical Formula (Hill Notation): C₁₇H₂₀N₂S · HCl
• CAS Number: 58-33-3
• Molecular Weight: 320.88
• Beilstein: 4166397
• EC Number: 200-375-2
• MDL number: MFCD00012652
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823397
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 421; traceable to Ph. Eur. P3400000; traceable to USP 1570009
• API family: promethazine
• CofA: current certificate can be downloaded
• packaging: pkg of 1 g
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C
• SMILES string: Cl[H].CC(CN1c2ccccc2Sc3ccccc13)N(C)C
• InChI: 1S/C17H20N2S.ClH/c1-13(18(2)3)12-19-14-8-4-6-10-16(14)20-17-11-7-5-9-15(17)19;/h4-11,13H,12H2,1-3H3;1H
• InChI key: XXPDBLUZJRXNNZ-UHFFFAOYSA-N
• Gene Information: human ... HRH1(3269)

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.

Promethazine hydrochloride belongs to the group of phenothiazine derivatives. It is commonly used as an antihistaminic for most prominently enhancing the anesthetic, sedative and analgesic effect of other drugs. It also shows antipyretic and antiemetic properties, when used in combination with paracetamol. It is also used to provide symptomatic relief of hypersensitivity reactions.

Application

Promethazine hydrochloride may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using spectroanalytical technique.

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 LRAA3015 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS05,GHS07,GHS09
• Signal Word: Danger
• Hazard Statements: H302,H317,H318,H411
• Precautionary Statements: P261 - P273 - P280 - P301 + P312 - P302 + P352 - P305 + P351 + P338
• Hazard Classifications: Acute Tox. 4 Oral - Aquatic Chronic 2 - Eye Dam. 1 - Skin Sens. 1
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 1
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable