Bulk Pharmaceutical API Sources for SORBITOL 3% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for SORBITOL 3% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		47841_SUPELCO
Sigma-Aldrich		S0900_SIGMA
Sigma-Aldrich		S1876_SIGMA

Bulk Active Pharmaceutical Ingredient (API) Sources for: Sorbitol 3% in Plastic Container

Last updated: August 13, 2025

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Introduction

Sorbitol, a sugar alcohol widely used in pharmaceutical and cosmetic formulations, functions primarily as a humectant, stabilizer, and sweetener. When prepared at a concentration of 3% in a plastic container, it often forms part of topical, oral, or ophthalmic products, where stability and purity are paramount. The sourcing of high-quality bulk API of sorbitol, suitable for pharmaceutical applications, demands rigorous supplier evaluation, robust quality assurance, and adherence to regulatory standards.

This article dissects the global landscape of API suppliers specializing in sorbitol suitable for pharmaceutical use, emphasizing the technical specifications, regulatory compliance, and logistical considerations vital for pharmaceutical manufacturers.

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Regulatory Framework and Quality Standards

API sourcing for pharmaceutical applications, especially for sorbitol intended for preparations in plastic containers, necessitates compliance with stringent regulatory standards:

• USP (United States Pharmacopeia) and EP (European Pharmacopoeia) monographs specify quality parameters including purity, heavy metals, residual solvents, and microbial limits.
• ICH guidelines ensure stability testing and good manufacturing practices (GMP) compliance.
• Suppliers must provide batch certification, purity profiles, and Certificates of Analysis (CoA).

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Leading Global API Suppliers for Sorbitol

1. Roquette Frères (France)

• Overview: A prominent manufacturer with decades of experience in producing sorbitol, including pharmaceutical-grade USP/EP specifications.
• Capabilities: Offers sorbitol powders and solutions with low moisture and high purity, suitable for formulating in plastic containers.
• Regulatory Compliance: GMP-certified, with extensive documentation aligning with global standards.
• Distribution: Global supply chain with established logistics infrastructure.

2. SPI Pharma (United States)

• Overview: A leader in pharmaceutical excipients and APIs, SPI Pharma supplies sorbitol grades aligned with pharmaceutical quality standards.
• Product Range: Provides sorbitol solutions optimized for stability in plastic packaging.
• Regulatory Standing: Complies with FDA regulations; supplies include detailed CoA and stability data.

3. Merck KGaA (Germany)

• Overview: A major supplier of pharmaceutical excipients, including sorbitol with both anhydrous and solution forms.
• Quality Assurance: Offers products with high purity, minimal residual solvents, and tailored specifications.
• Certifications: GMP, ISO certifications ensure compliance with international standards.

4. Jungbunzlauer (Switzerland)

• Overview: Known for sustainable manufacturing of sorbitol and derivatives at pharmaceutical purity levels.
• Product Customization: Supplies pharmaceutical-grade sorbitol solutions suitable for use in plastics for medicinal purposes.
• Regulatory Status: Meets global regulatory requirements with comprehensive documentation.

5. Ingredion (United States)

• Overview: Supplies sorbitol solutions with pharmaceutical-grade quality, catering to formulations requiring stability in plastic containers.
• Product Attributes: Consistent quality, low microbiological contamination, and suitable for parenteral or topical formulations.

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Regional and Emerging API Suppliers

• Sukhjit Starch & Chemicals Ltd. (India): Offers sorbitol USP-grade with competitive pricing, backed by certification complying with Indian AND international standards.
• Anhui Shinuo Pharmaceutical Co. Ltd. (China): Growing supplier with pharmaceutical-grade sorbitol, emphasizing GMP manufacturing.
• FMC Corporation (Global): Provides specialty sorbitol derivatives and solutions suitable for pharmaceutical formulations in plastic containers.

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Supply Chain Considerations

• Purity & Compatibility: Suppliers must provide products with a purity of ≥99%, low residual solvents, and tested microbial limits.
• Packaging: Suitable for plastic container formulation requires sorbitol solutions or powders stable in packaging materials like HDPE or polypropylene.
• Logistics & Lead Time: Consider supplier capacity, freight options, and regional logistics to ensure timely supply.
• Regulatory Documentation: Certificates of Analysis, Certificates of Suitability (CoS), batch traceability records, and stability data are essential.

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Quality Assurance and Validation

Pharmaceutical manufacturers must undertake thorough validation processes when sourcing sorbitol APIs:

• Verification of supplier credibility through audits and previous supply record assessments.
• Analytical testing to confirm purity, microbial limits, and residual solvents.
• Stability testing in the particular plastic container material to ensure long-term integrity of the sorbitol solution or powder.

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Conclusion

Sourcing high-quality sorbitol API for pharmaceutical products in plastic containers requires engagement with established, GMP-compliant suppliers. Roquette, SPI Pharma, Merck, Jungbunzlauer, and Ingredion stand out globally, offering products that meet the necessary pharmacopeial and regulatory standards. Considering regional suppliers like Sukhjit or Chinese manufacturers can offer cost advantages but mandates rigorous validation.

Manufacturers should prioritize supplier transparency, documentation, and compliance to ensure product integrity, regulatory adherence, and patient safety.

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Key Takeaways

• Extensive global suppliers, primarily Roquette, SPI Pharma, Merck, Jungbunzlauer, and Ingredion, provide pharmaceutical-grade sorbitol suitable for formulations in plastic containers.
• Regulatory compliance, certificates, and purity standards are non-negotiable in pharmaceutical API sourcing.
• Regional and emerging suppliers offer cost benefits but require rigorous validation.
• Packaging stability and logistics play critical roles in API selection for use in plastic containers.
• Robust quality assurance processes safeguard product efficacy and regulatory compliance.

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FAQs

Q1: What purity levels are required for sorbitol APIs used in pharmaceuticals?
A: Typically, sorbitol APIs should have a purity of ≥99%, with low residual solvents, microbial limits within pharmacopeial standards, and compliance with USP or EP specifications.

Q2: How important is GMP certification for sorbitol suppliers?
A: GMP certification ensures that the product complies with manufacturing standards essential for pharmaceuticals, minimizing contamination risks and ensuring batch-to-batch consistency.

Q3: Can sorbitol solutions be used directly in plastic containers?
A: Yes, pharmaceutical-grade sorbitol solutions are formulated to be stable in plastic containers. Suppliers often provide solutions designed for compatibility with packaging materials.

Q4: What factors influence the choice of a sorbitol supplier for pharmaceutical products?
A: Purity, regulatory compliance, supply reliability, cost, documentation, packaging compatibility, and the supplier’s reputation are key factors.

Q5: Are there specific considerations when storing sorbitol API in plastic containers?
A: Stability data provided by manufacturers is critical; proper storage conditions—temperature, humidity, light exposure—must be maintained to preserve API integrity over time.

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References

1. United States Pharmacopeia (USP) – Sorbitol Monograph.
2. European Pharmacopoeia (EP) – Sorbitol Monograph.
3. International Conference on Harmonisation (ICH) – Guideline for Good Manufacturing Practices (GMP).
4. Roquette Official Product Catalog and Quality Certificates.
5. SPI Pharma Product Datasheets and Certification Documents.