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1.41356 SAFC

Polyvinyl alcohol 28-99

EMPROVE® ESSENTIAL Ph Eur,JPE

Synonym: PVA, PVOH, Poly(vinyl alcohol)

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Properties

Agency/Method   JPE
  Ph. Eur.
Quality Level   500
product line   Emprove® Exp
potency   >2000 mg/kg LD50, oral (Rat)
mp   160-240 °C
bulk density   400‑670 kg/m3
InChI   1S/C2H4O/c1-2-3/h2-3H,1H2
InChI key   IMROMDMJAWUWLK-UHFFFAOYSA-N
storage conditions   Store at +5°C to +30°C.

Description

General description

When working on a pharmaceutical formulation, there are specific considerations to make and challenging hurdles to take before you can successfully launch your final drug product - formulation stability, release kinetics and bioavailability limitations just to name a few. With our application know-how and regulatory expertise, we support you in every step of development, scale-up, and production.
As part of our Emprove® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.

Application

Polyvinyl alcohol 28-99 is a synthetic, bio-compatible, toxicologically safe and multi-compendial polymer. It is part of a portfolio spanning a wide range of pharmaceutical grade polyvinyl alcohol of different viscosities, hydrolysis grades and molecular weights and is well suited for a broad variety of pharmaceutical applications, including solid, liquid, and semi-solid formulations.
The specification of the product is part of the Emprove® Material Qualification Dossier and can be found under "General Properties".

Analysis Note

Identity (IR spectrum)passes testIdentity (Viscosity)passes testIdentity (Reaction with iodine)passes testIdentity (Reaction with iodine and boric acid)passes testIdentity (Reaction with ethanol)passes testAppearance of solution (40 g/l, water)passes testAppearance of solution (50 g/l, water)passes testWater-insoluble matter (40 g/l, water)≤ 0.1 %pH-Value (40 g/l; water)5.0 - 6.5Dynamic viscosity (40 g/l; water)23.8 - 32.2 mPa∙sKinematic viscosity (40 g/l; water)23.8 - 32.2 mm²/sAs (Arsenic)≤ 2 ppmHeavy metals (as Pb)≤ 10 ppmCrotonaldehyde (GC)≤ 10 ppmAcetic acid (alkalimetric)≤ 0.5 %Methanol (GC)≤ 1.0 %Methyl acetate (GC)≤ 1.0 %Other residual solvents (ICH Q3C)excluded by production processEster value9 - 11Degree of hydrolysis (JPE)≥ 97 %Acid value≤ 3.0Saponification value≤ 30Sulfated ash≤ 1.0 %Loss on Drying (105 °C)≤ 5.0 %Endotoxins≤ 0.03 I.U./mgMicrobiological purity(Total aerobic microbial count (TAMC))≤ 100 CFU/gMicrobiological purity(Total yeast and mould count (TYMC))≤ 100 CFU/gBile-tolerant gram-negative bacteria(absent in 1 g)conformsEscherichia coli (absent in 1 g)conformsPseudomonas aeruginosa (absent in 1 g)conformsStaphylococcus aureus (absent in 1 g)conformsCandida albicans (absent in 1 g)conformsSalmonella (absent in 10 g)conformsElemental 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, JPE

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany

Safety & Documentation

Safety Information

Safety Information for this product is unavailable at this time.

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