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Propylene glycol | CAS No: 57-55-6 | GMP-certified suppliers
A medication that serves as a versatile excipient for diverse formulations, supporting solubility, stability, and moisture control across oral, topical, parenteral, and inhalation products.
Therapeutic categories
Product Snapshot
- Propylene glycol is supplied as a multifunctional excipient in liquid, gel, cream, spray, and solution-based formulations for topical, ophthalmic, nasal, oral, and extracorporeal use
- It is used primarily as a solvent, humectant, and vehicle in finished dosage forms rather than as a therapeutic agent
- It is approved for use in the US and Canada, with some investigational applications noted
Clinical Overview
Pharmacologically, propylene glycol exhibits low inherent biological activity. It supports drug delivery by enhancing solubility and stability of active ingredients, particularly for poorly water‑soluble molecules. It is used across oral, topical, parenteral, and inhalation formulations, where its physicochemical properties facilitate dispersion, viscosity modulation, and moisture retention.
A defined mechanism of action is not applicable because propylene glycol does not exert therapeutic effects. Its contribution to product performance is primarily physicochemical, affecting dissolution, absorption, and formulation consistency.
Absorption following oral or dermal exposure is efficient, and the compound distributes readily due to high water solubility. Metabolism occurs predominantly through hepatic alcohol dehydrogenase to lactate and pyruvate, which enter normal metabolic pathways. Elimination is mainly renal, with a short half‑life in individuals with normal organ function. Accumulation may occur in neonates or patients with impaired renal or hepatic clearance.
Safety considerations include the potential for hyperosmolality, metabolic acidosis, central nervous system depression, or hemolysis at high systemic exposures. Infants and patients receiving large cumulative doses through multiple medications are at increased risk. Local irritation is possible in topical or inhalation applications. The excipient is generally recognized as safe when used within established limits.
Propylene glycol appears in numerous branded and generic pharmaceutical products as a formulation aid rather than an active component. For API‑grade procurement, sourcing should focus on compliance with pharmacopeial specifications, control of impurities such as diethylene glycol, and verification of manufacturing traceability and stability data appropriate for intended dosage forms.
Identification & chemistry
| Generic name | Propylene glycol |
|---|---|
| Molecule type | Small molecule |
| CAS | 57-55-6 |
| UNII | 6DC9Q167V3 |
| DrugBank ID | DB01839 |
Pharmacology
Targets
| Target | Organism | Actions |
|---|---|---|
| B12-independent glycerol dehydratase | Clostridium butyricum |
Formulation & handling
- Highly water‑miscible small molecule suitable for aqueous topical, ophthalmic, nasal, and oral formulations, often functioning as a solvent or humectant.
- Chemically stable and non‑peptidic, with low volatility and good compatibility with gels, emulsions, and solution systems.
- Hygroscopic nature may require moisture‑controlled storage and packaging to maintain consistency in semisolid and liquid products.
Regulatory status
| Lifecycle | I don’t have patent‑expiry information for this API, so here is a neutral, placeholder summary you can adjust once the timing is known: The product is marketed in the US and Canada, indicating a mature North American presence. Its lifecycle position will depend on the patent expiry date; once patents expire, generic entry would be expected to shift the market into a late‑stage, post‑exclusivity phase. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Propylene glycol is a widely used excipient produced by numerous global chemical manufacturers rather than a single originator company, resulting in a broad and mature supply base. Branded products containing propylene glycol are available across the US and Canada, reflecting its established role in topical, ophthalmic, and disinfectant formulations. As a non‑patented commodity ingredient, it faces continuous and longstanding multi‑source competition. |
|---|
Propylene glycol is a type of Solvents
Solvents play a crucial role in the pharmaceutical industry as a subcategory of active pharmaceutical ingredients (APIs). These chemical compounds are employed for various purposes, including the extraction, purification, and formulation of drugs. Solvents are utilized in the production of pharmaceutical APIs to dissolve, suspend, or extract the desired substances from raw materials.
Pharmaceutical solvents possess specific characteristics that make them suitable for their intended applications. They exhibit high purity levels and low impurity profiles, ensuring the safety and efficacy of the final pharmaceutical products. Solvents are selected based on factors such as their ability to dissolve the API, compatibility with other ingredients, and regulatory compliance.
Common solvents used in the pharmaceutical industry include ethanol, methanol, acetone, and ethyl acetate. These solvents are known for their favorable properties such as high solvency power, volatility, and stability. However, the selection of a solvent depends on the specific requirements of the API and the manufacturing process.
It is crucial to ensure that solvents used in pharmaceutical manufacturing are of pharmaceutical grade and meet stringent quality standards. This guarantees the absence of impurities that could potentially affect the safety and efficacy of the pharmaceutical products. Regulatory authorities, such as the FDA, have established guidelines and specifications for pharmaceutical solvents to ensure their quality and safety.
In conclusion, solvents are an integral part of the pharmaceutical API subcategory. Their precise selection and utilization enable the extraction, purification, and formulation of drugs. The pharmaceutical industry relies on high-quality solvents to ensure the production of safe and effective medications.
Propylene glycol (Solvents), classified under Additives
Additives in the pharmaceutical API category refer to a group of chemical substances that are incorporated into pharmaceutical products to enhance their stability, functionality, or performance. These additives play a crucial role in ensuring the quality, safety, and efficacy of medications.
One common type of additive used in pharmaceuticals is preservatives. Preservatives are added to prevent microbial growth and maintain the integrity of the product throughout its shelf life. They help to safeguard against contamination and maintain the potency of the active pharmaceutical ingredient (API). Some commonly used preservatives include benzyl alcohol, phenol, and parabens.
Another important group of additives is antioxidants. Antioxidants are added to pharmaceutical formulations to prevent or delay the oxidation of APIs, which can lead to degradation and loss of potency. Examples of antioxidants commonly used in pharmaceuticals include ascorbic acid (vitamin C) and tocopherols (vitamin E).
In addition to preservatives and antioxidants, other additives like flavorings, colorants, and sweeteners may be incorporated into pharmaceutical products to improve their palatability and patient acceptability.
It is crucial to note that the use of additives in pharmaceuticals is strictly regulated by health authorities to ensure their safety and efficacy. Manufacturers must comply with stringent quality control standards and guidelines to guarantee the proper use and appropriate levels of additives in pharmaceutical products.
Overall, additives play a vital role in the pharmaceutical industry by enhancing the stability, functionality, and patient acceptability of medications. Their careful selection and incorporation contribute to the overall quality and effectiveness of pharmaceutical products.
Propylene glycol API manufacturers & distributors
Compare qualified Propylene glycol API suppliers worldwide. We currently have 5 companies offering Propylene glycol API, with manufacturing taking place in 4 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CoA, ISO9001, MSDS, WC | 250 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Spain | CoA, GMP, ISO9001, MSDS | 170 products |
| Hänseler AG | Distributor | Switzerland | Switzerland | CoA, GMP, MSDS | 174 products |
| Pharm Rx Chemical Corp | Distributor | United States | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
When sending a request, specify which Propylene glycol API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Propylene glycol API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Propylene glycol API
Sourcing
What matters most when sourcing GMP-grade Propylene glycol?
Which documents are typically required when sourcing Propylene glycol API?
Which manufacturers are known to produce Propylene glycol API?
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Technical
What is Propylene glycol (CAS 57-55-6) used for?
Which therapeutic class does Propylene glycol fall into?
What should someone know about the safety or toxicity profile of Propylene glycol?
What are important formulation and handling considerations for Propylene glycol as an API?
Is Propylene glycol a small molecule?
Are there special stability concerns for oral Propylene glycol?
Regulatory
Where is Propylene glycol approved or in use globally?
What’s the regulatory and patent landscape for Propylene glycol right now?
Pharmaoffer
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