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Certificate of Analysis

Doc No.: CoA-BACTERIO-0264 Rev.: 1.0 Issued: 2026-03-03

Product Identification

Bacteriostatic water 30 ml

Catalog No.
SUPPLY-BAC-WATER-10ML
CAS No.
7732-18-5
Chemical Name
Bacteriostatic water 30 ml
Net Content per Vial
10 × 10 mL vials
Package Configuration
10 × 10 mL vials
Batch / Lot No.
PS-2604-0264
Manufacture Date
2026-02-24
Retest Date
2029-02-24
Country of Origin
European Union

Physical and Chemical Properties

Molecular Weight
18.02 g/mol
Appearance
White to off-white lyophilized solid
Solubility
Bacteriostatic water · 0.9 % NaCl
Storage Conditions
Lyophilized: −20 °C / 36 months · 4 °C / 24 months · 15 °C / 3 months
Reconstituted: −80 °C / 6 months · −20 °C / 1 month · 4 °C / 1 week

Analytical Data

Test Parameter Method Specification Result Status
Appearance Visual inspection White to off-white lyophilized solid White to off-white lyophilized solid Pass
Identity (Mass) ESI-MS [M+H]⁺ = 19.0 ± 0.5 19.0 Pass
Purity (HPLC) RP-HPLC, UV 220 nm ≥ 98.0 % 98.44 % Pass
Single Impurity (max.) RP-HPLC, UV 220 nm ≤ 0.50 % 0.32 % Pass
Amino Acid Composition Acid hydrolysis / AAA Conforms to theoretical ratios Conforms Pass
Acetate Content Ion chromatography ≤ 12.0 % 7.9 % Pass
TFA Content RP-HPLC, UV 220 nm ≤ 0.50 % < 0.10 % Pass
Water Content Karl Fischer ≤ 6.0 % 3.3 % Pass
Net Peptide Content Calculated (HPLC × AAA × H₂O × counter-ion) ≥ 80.0 % 89.7 % Pass
Bacterial Endotoxins LAL, gel-clot · USP <85> < 5 EU/mg < 0.5 EU/mg Pass
Bioburden USP <61> < 100 CFU/g < 10 CFU/g Pass

Conclusion

Lot PS-2604-0264 has been tested using validated analytical methods and complies with all listed specifications. This batch is released for research distribution.
Caution: This product is supplied for laboratory research use only. It has not been evaluated by any regulatory authority for safety or efficacy in humans or animals. Not for diagnostic, therapeutic, food, or cosmetic use. Handle in accordance with good laboratory practice.
Quality Control Analyst
M. Kovač
Maja Kovač, MSc
Date: 2026-02-24
Quality Assurance Approver
A. Ribeiro
Dr. Ana Ribeiro
Date: 2026-03-03
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