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QUALITY/sirolimus

 

ACINOPEPTIDE // QUALITY                                            http://www.acinopeptide.com                                                                       


Acinopeptide strives to exceed our customers’ expectations. Our emphasis on quality assurance has helped acinopeptide gain a reputation worldwide for high quality products and provided our loyal customers confidence in committing to long terms supply agreements.  We are constantly upgrading every aspect of our quality systems in terms of staff training, documentation and analytical capabilities to achieve the highest levels possible. Acinopeptide is ISO 9001:2000 certified. Every product we ship includes a Certificate of Analysis with complete detailed information on lot number, product information, date of manufacturing, date of expiry, specification and typical analysis data. The quality of our products is one of our most significant assets.

We always welcome our customers for visiting acinopeptide and/or audits at a convenient time.

 

Our fundamental quality policy is:

+ Understand Customer need

+ Comply with National and international requirements

+ Implementation of requirements to products and organization

+ Check implementation

+ Communication to customer

+ Long term customer care

 

We have the following procedures in our quality systems to monitor the quality of products throughout the whole manufacturing process and even up to inventory: 

+ Raw Material Quality Inspection (RMQ)

+ In-Process Quality Inspection (IPQ)

+ Final Product Quality Inspection (FPQ)

+ Certificate of Analysis (CoA) for our every lot of products

+ Maintain retained samples for each lot for at least one year

+ Shelf-life analysis data

 

List of Analytical Techniques used in the Inspection of Products include: 

+ HPLC analysis

+ RP-HPLC (reversed phase)

+ SEC-HPLC (size exclusion)

+ IE-HPLC (ion exchange)

+ method develpment and validation for Non-GMP and GMP projects.

+ Mass Spectrometric analysis

+ ESI-MS full scan

+ LC-MS

+ LC-MS-MS

+ Amino Acid Analysis

+ Proteins/peptides are hydrolyzed using HCl. The released amino acid residues are analyzed on a reversed phase HPLC after pre-column derivatization.

+ Water Content

+ Moisture Analysis by Karl Fisher titration

+ Peptide content

+ by elemental analysis

+ Peptide counter ion content

+ TFA, Acetic Acid content by HPLC

+ Residual Solvent content

+ DMF, DCM, ACN content by GC

+ UV

+ qualitative and quantitative analysis

+ Melting Point

+ Elemental Analysis