Glycerol 99% Synthetic, EP, USP, PharmProve

Over 72% of India’s pharmaceutical formulations now rely on high-purity excipients like Glycerol 99% Synthetic to ensure stability, safety, and consistent performance.
pharmon
By pharmon
3 Min Read

With compliance to EP (European Pharmacopoeia), USP (United States Pharmacopeia), and PHARMPROVE standards, this excipient has become indispensable for pharmaceutical manufacturers targeting both domestic and export markets.

What is Glycerol 99% Synthetic?

Glycerol, also known as glycerin, is a clear, odorless, hygroscopic liquid.

  • In its 99% synthetic form, it is produced via refined petrochemical or plant-based synthesis.
  • It ensures high purity, absence of microbial contamination, and no heavy metal traces.
  • Vital for oral, topical, ophthalmic, and parenteral dosage forms.

Key Pharmaceutical Applications

  • Cough Syrups Acts as a humectant, maintaining moisture and viscosity.
  • Capsules & Tablets Serves as a plasticizer in gelatin shells, preventing brittleness.
  • Ophthalmic Solutions Works as a lubricant to reduce eye irritation and dryness.
  • Injectables Balances tonicity due to its osmotic properties.

Importance of EP & USP Compliance

EP and USP standards define purity, identity, and impurity limits. For Glycerol 99% Synthetic, compliance means:

  • Zero harmful residual solvents
  • Precise moisture control
  • Verified chemical identity

The PHARMPROVE label adds an extra guarantee, confirming rigorous quality audits and manufacturing best practices.

  • Pharma Exports Growth India’s exports exceed $25 billion annually.
  • Urban Consumer Awareness Age group 36–60 in cities like Mumbai, Bengaluru, and Delhi now demands ingredient transparency.
  • Stricter Regulations CDSCO is enforcing tighter excipient quality norms.

Sustainability in Production

Although synthetic glycerol is traditionally petrochemical-derived, a green shift is underway:

  • Plant-based synthesis from sustainable vegetable oils (palm-free).
  • Lower carbon footprint in manufacturing.
  • Aligns with eco-conscious consumer values.

Ensuring Supply Chain Reliability

  • Direct partnerships with global producers
  • Strategic stock reserves in bonded warehouses
  • Batch-level documentation including CoA and microbiological reports

Case Study: Ophthalmic Success Story

A Mumbai-based drug manufacturer replaced standard glycerol with PHARMPROVE Glycerol 99% Synthetic for preservative-free eye drops.

  • Result: Better shelf stability, reduced viscosity issues, and faster international approvals.
  • Impact: Increased market acceptance in regulated countries.

Global Market Perspective

  • Price Stability Despite raw material fluctuations, glycerol remains steady.
  • Premium for EP/USP Grade Higher demand in Europe & North America.
  • Export Advantage Indian suppliers meeting global compliance can capture more market share.

Looking Ahead

With India moving toward ICH-aligned GMP regulations, the demand for high-purity excipients will rise. Manufacturers prioritizing quality, sustainability, and compliance in glycerol sourcing will have a competitive edge.

Consumer Takeaway

For nature-conscious buyers, excipients are just as important as active ingredients. Products containing PHARMPROVE Glycerol 99% Synthetic are more likely to be safe, effective, and globally compliant.

Call to Action

Pharma manufacturers, formulators, and exporters this is the time to secure sustainable and certified glycerol supplies.

  • Purity that meets global pharmacopeial standards
  • Consistency in every batch
  • Market readiness for regulated exports

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