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Lactic Acid 90% Pharma
Galacid Pharma 90 is a pharmaceutical-grade natural lactic acid produced by Galactic through fermentation from sugar. It is colorless, heat stable, and has a mild acid taste. This product meets the stringent purity requirements of the European Pharmacopoeia (EP) and United States Pharmacopeia (USP).
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- Manufacturer: Galactic
- Product Line: Galactic Lactic Acid
- Product: Galactic Lactic Acid Food
- Industries:
- Authorized Countries: United States
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Overview
Galacid Pharma 90 is a pharmaceutical-grade natural lactic acid produced by Galactic through fermentation from sugar. It is colorless, heat stable, and has a mild acid taste. This product meets the stringent purity requirements of the European Pharmacopoeia (EP) and United States Pharmacopeia (USP).
Pharmaceutical-grade lactic acid is used in a range of healthcare applications, including as an excipient in topical and oral formulations, in dialysis solutions, and as a pH adjuster in parenteral products. The high stereochemical purity (min. 97% L+) and extremely tight impurity specifications make Galacid Pharma 90 suitable for the most demanding pharmaceutical manufacturing processes.
The product also undergoes additional purity testing beyond food-grade requirements, including tests for methanol (not detectable), volatile fatty acids, readily carbonizable substances, and ether-insoluble substances, ensuring it meets the rigorous standards expected in pharmaceutical production.
Specifications
Chemical name: 2-Hydroxypropanoic acid
Molecular formula: C3H6O3
Molecular weight: 90 g/mol
CAS number: 79-33-4
Density (@20°C): 1.20 – 1.21 g/mL
Solubility: Soluble in water and ethanol
Total acidity (as lactic acid): 89.5 – 90.5% w/w
Stereochemical purity: Min. 97% L+
Color (fresh): Max. 10 Hazen
Color after heating (@200°C, 2h): Max. 50 Hazen
Heavy metals (as Pb): Max. 5 ppm
Iron: Max. 5 ppm
Methanol: Not detectable
Volatile fatty acids: Passes test
Shelf life: 48 months
Certifications: Kosher, Halal, GRAS, European Pharmacopoeia (EP), USP
Features & Benefits
- Pharmaceutical grade meeting European Pharmacopoeia (EP) and USP monographs
- Total acidity: 89.5 – 90.5% w/w with min. 97% stereochemical purity
- Tighter impurity limits: Heavy metals max. 5 ppm, Iron max. 5 ppm
- Methanol: Not detectable; passes volatile fatty acids and carbonizable substances tests
- Color (fresh): Max. 10 Hazen, significantly tighter than food-grade specifications
- Heat stable with color after heating: Max. 50 Hazen
- Kosher and Halal certified; GRAS status
- 48-month shelf life
Problems Solved
Meeting strict pharmacopoeia purity requirements (EP, USP) for pharmaceutical manufacturing Need for ultra-low impurity lactic acid in parenteral and dialysis solution production Color-sensitive pharmaceutical formulations requiring very low initial color (Max. 10 Hazen) Traceability and quality requirements for pharmaceutical supply chains Need for a fermentation-derived, naturally sourced excipient in pharmaceutical products
Applications
Pharmaceutical excipients, topical and oral drug formulations, dialysis solutions, parenteral products (pH adjustment), and pharmaceutical manufacturing processes requiring EP and USP compliance.
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