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PHR1162

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Loperamide hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

LPM, 4-(p-Chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-1-piperidinebutyramide hydrochloride

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About This Item

Empirical Formula (Hill Notation):
C29H33ClN2O2 · HCl
CAS Number:
Molecular Weight:
513.50
EC Number:
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to BP 635
traceable to Ph. Eur. L0750000
traceable to USP 1370000

API family

loperamide

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

Cl.CN(C)C(=O)C(CCN1CCC(O)(CC1)c2ccc(Cl)cc2)(c3ccccc3)c4ccccc4

InChI

1S/C29H33ClN2O2.ClH/c1-31(2)27(33)29(24-9-5-3-6-10-24,25-11-7-4-8-12-25)19-22-32-20-17-28(34,18-21-32)23-13-15-26(30)16-14-23;/h3-16,34H,17-22H2,1-2H3;1H

InChI key

PGYPOBZJRVSMDS-UHFFFAOYSA-N

Gene Information

human ... OPRM1(4988)

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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.
Loperamide hydrochloride finds application in the regulation and symptomatic relief of long acting diarrhea linked with inflammatory bowel diseases. It can also be used as a muscle relaxant agent.

Application

Loperamide hydrochloride may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by spectrophotometric and 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.

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.
Values of analytes vary lot to lot.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC3771 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Skull and crossbones

Signal Word

Danger

Hazard Statements

Precautionary Statements

Hazard Classifications

Acute Tox. 3 Oral

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


Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

JAN Code

PHR1162-1G-PW:
PHR1162-1G:


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Spectrophotometric determination of loperamide hydrochloride by acid-dye and charge-transfer complexation methods in the presence of its degradation products
El Sherif ZA, et al.
Journal of Pharmaceutical and Biomedical Analysis, 22(1), 13-23 (2000)
Spectrofluorimetric and derivative absorption spectrophotometric techniques for the determination of loperamide hydrochloride in pharmaceutical formulations
Hewala II
Journal of Pharmaceutical and Biomedical Analysis, 13(6), 761-767 (1995)
Effect of finite doses of propylene glycol on enhancement of in vitro percutaneous permeation of loperamide hydrochloride
Trottet L, et al.
International Journal of Pharmaceutics, 274(1-2), 213-219 (2004)
James Church et al.
Diseases of the colon and rectum, 56(1), 120-125 (2012-12-12)
Coating of the cecum with sticky bile causes a problem with inspection of the mucosa during colonoscopy. This study aimed to see whether 4 mg of loperamide taken after colonoscopy preparation would delay the passage of bile and improve the
Arnold Wald
Best practice & research. Clinical gastroenterology, 26(5), 573-580 (2013-02-07)
IBS is a functional gastrointestinal disorder which has been subtyped according to bowel habits. This review presents recommendations for IBS-D which makes up about 1/3 of all patients and which is defined as IBS with loose or watery stools with

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