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1.41354 SAFC

Polyvinyl alcohol 5-88

EMPROVE® ESSENTIAL Ph Eur,USP,JPE

Synonym: PVA, PVOH, Poly(vinyl alcohol)

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Properties

Agency/Method   JPE
  Ph. Eur.
  USP
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 +15°C to +25°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 5-88 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 test
Identity (Viscosity): passes test
Identity (Reaction with iodine): passes test
Identity (Reaction with iodine and boric acid): passes test
Identity (Reaction with ethanol): passes test
Appearance of solution (40 g/l, water): passes test
Appearance of solution (50 g/l, water): passes test
Water-insoluble matter (40 g/l, water): ≤ 0.1 %
pH-Value (40 g/l; water): 5.0 - 6.5
Viscosity (40 g/l; water): 4.3 - 5.7 mPa∙s
As (Arsenic): ≤ 2 ppm
Heavy metals (as Pb): ≤ 10 ppm
Crotonaldehyde (GC): ≤ 10 ppm
Acetic acid (alkalimetric): ≤ 0.5 %
Methanol (GC): ≤ 1.0 %
Methyl acetate (GC): ≤ 1.0 %
Other residual solvents (ICH Q3C): excluded by production process
Ester value: 130 - 150
Degree of hydrolysis (USP): 85 - 89 %
Degree of hydrolysis (JPE): 78 - 96 %
Acid value: ≤ 3.0
Saponification value: 132 - 152
Sulfated ash: ≤ 1.0 %
Loss on Drying (105 °C): ≤ 5.0 %
Endotoxins: ≤ 0.03 I.U./mg
Microbiological purity(Total aerobic microbial count (TAMC)): ≤ 100 CFU/g
Microbiological purity(Total yeast and mould count (TYMC)): ≤ 100 CFU/g
Bile-tolerant gram-negative bacteria(absent in 1 g): conforms
Escherichia coli (absent in 1 g): conforms
Pseudomonas aeruginosa (absent in 1 g): conforms
Staphylococcus aureus (absent in 1 g): conforms
Candida albicans (absent in 1 g): conforms
Salmonella (absent in 10 g): conforms
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,USP,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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