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100366 Kyselina (S)-mliečna, asi 90 %

vhodná na použitie ako excipient EMPROVE® EXPERT Ph Eur,BP,E 270

Kyselina (S)-mliečna, asi 90 % MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: 2-Hydroxypropionic acid, Lactol

Grade: Ph Eur,BP,E 270
100366
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Overview

Replacement Information

Key Spec Table

Grade Value
Ph Eur,BP,E 270

Products

Catalogue NumberPackaging Qty/Pack
1003662500 Plastová flaša 2.5 l
1003669025 Plastový kanister 25 l
Description
Catalogue Number100366
Synonyms2-Hydroxypropionic acid, Lactol
References
Product Information
GradePh Eur,BP,E 270
HS Code2918 11 00
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Boiling point122 °C (20 hPa)
Density1.21 g/cm3 (20 °C)
Melting Point18 °C
pH value2.8 (10 g/l, H₂O, 20 °C)
Vapor pressure0.1 hPa (25 °C)
Dimensions
Materials Information
Toxicological Information
Safety Information according to GHS
Hazard Pictogram(s) Hazard Pictogram(s)
Hazard Statement(s)H314: Spôsobuje vážne poleptanie kože a poškodenie očí.
EUH071: Žieravé pre dýchacie cesty.
Precautionary Statement(s)P280: Použite ochranné rukavice/ ochranný odev/ ochranu očí/ ochranu tváre/ ochranu sluchu.
P303 + P361 + P353: PRI KONTAKTE S POKOŽKOU (alebo vlasmi): Vyzlečte všetky kontaminované časti odevu. Pokožku ihneď opláchnite vodou.
P304 + P340 + P310: PO VDÝCHNUTÍ: Presuňte osobu na čerstvý vzduch a umožnite jej pohodlne dýchať. Okamžite volajte TOXIKOLOGICKÉ INFORMAČNÉ CENTRUM/lekára.
P305 + P351 + P338: PO ZASIAHNUTÍ OČÍ: Niekoľko minút ich opatrne vyplachujte vodou. Ak používate kontaktné šošovky a je to možné, odstráňte ich. Pokračujte vo vyplachovaní.
P363: Kontaminovaný odev pred ďalším použitím vyperte.
P405: Uchovávajte uzamknuté.
Signal WordNebezpečenstvo
Storage class8A Horľavé, leptavé nebezpečné látky
WGKWGK 1 mierne ohrozujúce vody
Disposal3
Relatívne nereaktívne organické reagencie je potrebné zhromaždovať v nádobe A. Ak sú halogénované, je potrebné ich zhromaždovať v nádobe B. Pre tuhé zvyšky použite nádobu C.
Safety Information
Categories of dangerdráždivá
Product Usage Statements
Storage and Shipping Information
StorageSkladujte pri +2°C až +25°C.
Packaging Information
Transport Information
Declaration (railroad and road) ADR, RIDUN 3265 , 8, III
Declaration (transport by air) IATA-DGRUN 3265 , 8, III
Declaration (transport by sea) IMDG-CodeUN 3265 , 8, III, Segregation Group: 1 (Acids)
Supplemental Information
Specifications
Assay (alkalimetric)88.0 - 92.0 %
Assay (stereochemical purity of (S)-lactic acid)≥ 95.0 %
Identity (IR-spectrum)passes test
Identity (pH)passes test
Identity (Density)passes test
Identity (Lactat)passes test
Identity (assay)passes test
Appearanceclear, oily liquid, not more intense in color than reference solution Y₆
Ether-insoluble substancespasses test
Citric, oxalic and Phosphoric acidspasses test
Density (d 20/20)1.20 - 1.21
Chloride (Cl)≤ 0.2 %
Sulfate (SO₄)≤ 200 ppm
As (Arsenic)≤ 3 ppm
Ca (Calcium)≤ 200 ppm
Fe (Iron)≤ 10 ppm
Hg (Mercury)≤ 1 ppm
Pb (Lead)≤ 2 ppm
Ethanol≤ 5000 ppm
Acetic acid≤ 5000 ppm
Methanol≤ 50 ppm
Other residual solvents (ICH Q3C)excluded by manufacturing process
Sugars and other reducing substancespasses test
Sulfated ash (600 °C)≤ 0.10 %
Total aerobic microbial count (TAMC)≤ 10²
Total combined yeasts/moulds count (TYMC)≤ 10²
Bacterial endotoxins≤ 5 I.U./g
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Corresponds to Ph Eur,BP, E 270
Conforms to the purity criteria on food additives according to European Commission directive 2008/84/EC.
Global Trade Item Number
Catalogue Number GTIN
1003662500 04022536005775
1003669025 04027269142483

Documentation

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Kyselina (S)-mliečna, asi 90 % MSDS

Title

Safety Data Sheet (SDS) 

Kyselina (S)-mliečna, asi 90 % Certificates of Analysis

Product Number PackagingSpecificationLot Number
1003662500 Plastová flašaPDF Specification Document
1003669025 Plastový kanisterPDF Specification Document

Certificates

Title
KOSHER Certificate for 100366 (S)-Lactic acid about '0% suitable for use as excipient EMPROVE® exp Ph Eur,BP,E 270

Technical Info

Title
Malt Extract Agar, 105398
Malt Extract Broth, 105397
Wort Agar, 105448
Wort Broth, Base, 105449

Related Products & Applications

Accessories (Secondary)

Catalogue Number Description
105397 Bujón so sladovým extraktom
105398 Agar so sladovým extraktom
105448 Wort agar
105449 Wort bujón (základ)

Categories

Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Acidulants and pH Adjustments
Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Ingredients - Semi Solid
IVD/OEM Materials & Reagents > Microscopy > Bacteriology > Auxiliaries for Bacteriology
Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > pH Adjustments and Isotonizers
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > pH Adjustments and Isotonizers