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Ipratropium EP Impurity A

(8R)-3α-Hydroxy-8-isopropyl-1αH,5αH-tropanium Bromide; (endo,syn)-3-Hydroxy-8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]octane Bromide; (3-endo,8-syn)-3-Hydroxy-8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]octane Bromide (1:1);

Ipratropium EP Impurity A | 58005-18-8 | Ipratropium Bromide

Specifications:

CAS No.

: 58005-18-8

Mol F.

: C11H22BrNO

Mol W.

: 264.2

Cat No.

: SA36001

Appearance

Pack Size Price Availability
25 mg $150 In Stock
50 mg $250 In Stock
100 mg $350 In Stock
200 mg $550 In Stock
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Product Name

: Ipratropium EP Impurity A

CAS No.

: 58005-18-8

Mol F.

: C11H22BrNO

Mol W.

: 264.2

Cat No.

: SA36001

Appearance

Synonyms

: (8R)-3α-Hydroxy-8-isopropyl-1αH,5αH-tropanium Bromide; (endo,syn)-3-Hydroxy-8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]octane Bromide; (3-endo,8-syn)-3-Hydroxy-8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]octane Bromide (1:1);

Related API

: Ipratropium Bromide

Category

Ipratropium EP Impurity A product with CAS: 58005-18-8 is also known as (8R)-3α-Hydroxy-8-isopropyl-1αH,5αH-tropanium Bromide; (3-endo,8-syn)-3-Hydroxy-8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]octane Bromide (1:1). This product can be used as a working standard or secondary reference standard (additional internal validation as per respective FDA regulations/guidelines may require). Ipratropium EP Impurity A is used in Ipratropium Bromide impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines during commercial production of Ipratropium Bromide and its related formulations. Moreover, (8R)-3α-Hydroxy-8-isopropyl-1αH,5αH-tropanium Bromide is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation. Please also find out other impurities of Ipratropium Bromide developed in our R&D.

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Disclaimer

This impurity material may be used as a working standard or secondary reference standard, provided it is appropriately characterized, identified, and qualified for its intended use. Additional internal validation may be required in accordance with applicable FDA regulations and guidance documents.

These impurity standards are typically used for various regulatory and quality-related purposes, including: ANDA and DMF filings, Toxicological studies, Quality Control, Analytical method development and validation in pharmaceutical sector.

The product information provided on this webpage is based on the best available knowledge at the time of publication. However, accuracy and completeness are not guaranteed. The purchaser, user, or importer of record is responsible for verifying the product specifications and details at the time of ordering, as they may change without prior notice.

This product is intended strictly for research purposes and is not approved for human consumption.