GlycylGlycine

PharmaGrade, Manufactured under appropriate GMP controls for pharma or biopharmaceutical production

Product Regulatory Datasheet

1. General Product Information

Product Name GlycylGlycine
Product Number G0674
Qualifier PharmaGrade, Manufactured under appropriate GMP controls for pharma or biopharmaceutical production.
Quality Level GMP
Related documents Cherokee GMP Site Quality System Overview
Cherokee Site and Supply Chain Security Overview

2. Manufacturing, Packaging, Release Site and Supplier Information

Site of manufacturing, testing, packaging and product release:

  • SAFC, 3300 S. Second St., St. Louis, MO 63118 USA (also known as the Cherokee GMP site of Sigma-Aldrich)
  • Testing for arsenic (USP) is performed by an approved service supplier: Galbraith Labs, Knoxville, TN 37921 USA; Testing for sodium (ICP) is performed by Sigma-Aldrich, 3500 Dekalb St., St. Louis, MO 63118.

Administrative headquarters and distribution shipping point:

  • Sigma-Aldrich, 3050 Spruce St., St. Louis, MO 63103

This product is manufactured under appropriate cGMP to be used in pharma or biopharmaceutical production.

This product is manufactured in multi-use equipment with appropriate cleaning controls in place.

3. Physico-chemical Information

3.1 Synonyms

Gly-gly; Diglycine; Glycyl-glycine

3.2 Linear Formula

NH2CH2CO(NH)CH2COOH

3.3 Molecular Formula:

C4H8N2O3

3.4 Molecular Mass

132.12

3.5 CAS Number

[556-50-3]

3.6 Origin

The product G0674 is manufactured synthetically using only raw materials of synthetic organic and inorganic origin.

3.7 Manufacturing process

Manufacturing process includes hydrolysis of glycine anhydride, purification by precipitation in ethanol, and drying at 30 +/- 5oC under vacuum.
Manufacturing process is validated, with process parameters for critical processing points and in-process testing.
Contact surfaces during production are Glass, Stainless Steel and PTFE (Teflon).
Equipment cleaning is verified.

3.8 Specification

Analytical items Specifications
Appearance (color)
Appearance (form)
White
Powder
Identity by IR Consistent with structure and compares properly to Spectrum 1,364B in the Sigma Library of FT-IR spectra.
Appearance of Solution (Color) at 15% (w/w) in water Colorless
Loss on Drying by USP <731> (105oC for 24 hours) ≤ 1.0%
Purity (TLC) ≥ 99%
Impurity (by TLC) - glycine ≤ 0.5%
Residual ethanol by GC ≤ 0.5%
Glycine by amino acid analysis ≤ 0.2%
Assay by perchloric acid titration (dry basis) ≥ 99.0%
Chloride by USP <221> ≤ 0.005%
Sulfate by USP <221> ≤ 0.005%
Sodium by ICP ≤ 0.01%
Arsenic by USP <211> Method II ≤ 5 ppm
Heavy Metals (as lead) by USP <231> method I ≤ 5 ppm
pH (5% w/v in water) 5.0 – 6.5
Enumeration by membrane filtration per USP <61>:
   Total Aerobic Microbial Count
   Total Yeast and Mold Count
   Total plate count


<100 CFU/g
Report result
Report result

3.9 Batch results

Certificates of Analysis are available for each lot produced.

4. Regulatory Information

4.1 Compendial compliance

Not applicable. There is no compendial monograph for glycylglycine.

4.2 Master file

Drug Master File (DMF) may be developed upon request.
EDQM Certificate of Suitability is not currently available for this product.
Please contact Sigma-Aldrich for further regulatory support.

4.3 BSE/TSE and viral risk statement

This product is not produced using components from animal species (bovine, ovine or caprine) know to harbor BSE/TSE, and is therefore considered negligible risk. It is manufactured from synthetic raw materials and in an animal component-free facility.

4.4 Allergen information

This product is not produced with any known major food allergens (as defined by the FDA and WHO). The product contains no additives.

4.5 GMO information

The product is not produced using GMOs and is considered GMO free.

4.6 Residual solvents information

The product is produced using only Class 3 solvent of ethanol according to USP <467> and CPMP/ICH/285/95. Product has specification of < 0.5% ethanol by GC.

4.7 Metal catalyst and metal reagent residues

The product is produced without use of metal catalysts or metal reagents.

4.8 Kosher/Halal status

No status.

4.9 Melamine statement

This material is not assayed by a test that detects nitrogen. This product is considered negligible risk for melamine contamination.

5. Miscellaneous Product Information

5.1 Explanation of the lot/batch numbering system

The product is manufactured in a batch process.
Batch size is approximately 70 to 80 kg.
Each produced batch is identified by a specific, unique batch number.
The batch number consists of 4 letters, followed by 4 digits and optionally a ‘V’, e.g. SLBC1234(V).

5.2 Expiration date and/or recommended re-evaluation interval:

Recommended retest period of 3 years from QC release date.
The retest date is based on a stability study.

5.3 Handling, Shipping Conditions and Long-term Storage Recommendation

If stored in the original unopened containers under specified conditions, no significant change of the material can be observed.
Storage and shipping conditions:

  • Store at room temperature, <60% humidity.
  • Ship at ambient temperature.

5.4 Packaging

Standard pack sizes of 100g:

  • Primary packaging materials: Polyethylene bags with twist ties.
  • Secondary packaging materials: Buckets or drums with tamper-evident ties.

Custom pack sizes for larger quantities (available upon request).

6. Revision History

Please note that updates are communicated only to customers with Change Notification Agreements.

7. Contact Information

Please contact your local Sigma-Aldrich representative for more information: SAFC worldwide offices

 

Cherokee GMP Site Quality Overview

SAFC® Fine Chemicals is a trusted manufacturer of specialty chemicals and biologics for life sciences and high technology commercial applications. We provide unique and innovative technologies and services for customers requiring a reliable partner throughout the development and manufacturing process. The Sigma-Aldrich group includes SAFC facilities that are able to adapt their supply chain and quality management systems to support your raw materials supply requirements for industrial use. Specialized services can be provided to assist throughout your process or program. This includes contract manufacturing, supply chain services, analytical services for method development programs and validation activities. SAFC® is the custom manufacturing unit of Sigma-Aldrich and has 30 manufacturing sites worldwide. SAFC will provide information as appropriate in support of the Chemistry and Manufacturing Controls sections of regulatory filings.

The SAFC site at Cherokee (intersection of S. Second St. & Cherokee St. in St. Louis) encompasses GMP manufacturing of API’s, biologics, excipients, intermediates, processing aids and raw materials for the pharmaceutical industry. Separate facilities are maintained for animal and non-animal protein purification, bio-organics and high-potency antibody conjugates.

1. Facility overview

1.1 Scope

  • SAFC, 3300 S. Second St., St. Louis, MO 63118 USA, internally referred to as the Cherokee site of Sigma-Aldrich.
  • This document pertains to the GMP product lines (proteins, bio-organics) manufactured at this address, and as such, does not include the biological buffers, tableted or packeted buffers/substrates or histological/hematological reagents produced at other facilities within this site.

1.2 Corporate ownership

  • SAFC is a wholly owned subsidiary of Sigma-Aldrich Corporation, 3050 Spruce St., St. Louis, Missouri 63103 USA.

1.3 Customer audit policy

  • Customers are welcome to audit our sites.
  • All inspections are planned, coordinated and accompanied by Quality Assurance; a thirty-day notice and confidentiality agreement may e required.

1.4 Site details

  • General site information:
        -    390,000 ft2 (36,000 m2) total for site
                12,000 ft2 (1,100 m2) for bio-organics area
                25,000 ft2 (2,300 m2) for protein purification areas
        -    250 employees for site (8,000 Sigma-Aldrich employees world-wide in 38 countries)
                ~40 in cGMP manufacturing
                ~20 Quality Assurance for site
                ~35 Quality Control for site
        -    Site operational since 1986 with upgrade in 1995 (Sigma-Aldrich was established in 1945)
        -    Production operates continuously (24 hours, 7 days/week for bio-organics; and 2 shifts, 5 days/week for protein purification)
  • Site activities conducted: Manufacturing, process development, testing, packaging, and raw material and bulk storage
  • Primary applications of products:
    API’s, biologics, excipients, intermediates, processing aids and raw materials for the pharmaceutical industry
  • No production or packaging of antibiotics, toxins, steroids or hormone products outside of the segregated high-potency antibody conjugates area.
  • Product release is a QA responsibility, with reporting independent of Manufacturing. Quality Assurance is responsible for raw material approval, manufacturing batch and packaging record review, certificate generation and product release.
  • Sub-contractors are qualified as part of our internal service supplier qualification program and are used in some instances of preventive maintenance and calibration, for γ-irradiation and for pest control, and may be contracted for special validation or testing requests if not met by our in-house capabilities.
  • Organizational charts available upon request.

 

 

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