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PHR1302

Supelco

Pramoxine hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Pramoxine hydrochloride, 4-[3-(4-Butoxyphenoxy)propyl]morpholine hydrochloride

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About This Item

Empirical Formula (Hill Notation):
C17H27NO3 · HCl
CAS Number:
Molecular Weight:
329.86
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 USP 1554002

API family

pramoxine

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.CCCCOc1ccc(OCCCN2CCOCC2)cc1

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General description

Pramoxine hydrochloride is a hydrochloride salt of pramoxine, widely used for its local anesthetic and antipruritic properties. Its ability to relieve itching arises from its stabilizing effect on the neuronal membranes of the nerve terminals. It is widely used as a pain medicine for various conditions such as skin irritations, rashes, hemorrhoids, and minor wound care. [1][2][3]
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.

Application

Pramoxine hydrochloride may be used as a pharmaceutical reference standard in the determination of the analyte in pharmaceutical formulations by chromatographic technique.[3][4]
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

Topical anesthetic for skin or mucous membranes

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 LRAA1519 in the slot below. This is an example certificate only and may not be the lot that you receive.

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Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Precautionary Statements

Hazard Classifications

Acute Tox. 4 Oral - Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3

Target Organs

Respiratory system

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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    Comparative study of two different chromatographic approaches for quantitation of hydrocortisone acetate and pramoxine hydrochloride in presence of their impurities
    Ibrahim F, et al.
    Journal of food and drug analysis, 26(3), 1160-1170 (2018)
    Simultaneous determination of pramoxine HCl and benzalkonium chloride in wound care solutions by HPLC
    Tavlarakis P,et al
    Analytical Methods : Advancing Methods and Applications, 2(6), 722-727 (2010)
    Efficacy and onset of action of hydrocortisone acetate 2.5% and pramoxine hydrochloride 1% lotion for the management of pruritus: results of a pilot study
    Kircik LH
    The Journal of Clinical and Aesthetic Dermatology, 4(2), 48-48 (2011)
    Gary Grove et al.
    Cutis, 73(2), 135-139 (2004-03-19)
    An open-label, single-center, observer-blinded, controlled trial was conducted during the winter months to evaluate the moisturizing and antipruritic effects of a unique formulation of lactic acid 12% neutralized with ammonium hydroxide and pramoxine hydrochloride (HCl) 1% in 24 women with

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