Sorbitol Powder USP/BP/EP Grade 99% — Pharmaceutical Excipient & Humectant for Toothpaste, Mouthwash, Tablet & Personal Care CAS 50-70-4

Sorbitol Powder USP/BP/EP Grade 99% — Pharmaceutical Excipient & Humectant for Toothpaste, Mouthwash, Tablet & Personal Care CAS 50-70-4

Product Attributes

Packaging & Logistics

Product Description

What is Sorbitol Powder USP/BP/EP Grade?

Sorbitol is a hexahydric sugar alcohol produced by catalytic hydrogenation of glucose. Our pharmaceutical grade sorbitol powder meets USP, BP, and EP monographs with ≥ 99.0% purity — the highest standard available for pharmaceutical, oral care, and personal care manufacturers who require pharmacopoeia-grade ingredients.

Unlike food-grade sorbitol, our USP/BP/EP grade undergoes additional purification steps and stricter microbial controls (≤ 100 CFU/g TAMC vs. ≤ 1,000 CFU/g for food grade), making it suitable for direct patient-contact applications.

Why USP/BP/EP Grade Sorbitol?

Applications

1. Oral Care — Toothpaste & Mouthwash

Sorbitol powder is the #1 humectant and sweetener in toothpaste formulations worldwide. It replaces glycerol in cost-sensitive formulations while delivering superior performance:

Humectancy

• — prevents toothpaste from drying out in the tube; maintains ribbon consistency for 24+ months

Non-cariogenic sweetness

• — provides pleasant mouthfeel without feeding oral bacteria

Tooth-friendly

• — recognized by FDI and ADA as safe for teeth

Abrasive suspension

• — ideal viscosity for suspending silica and calcium carbonate abrasives

Flavor compatibility

• — neutral taste profile that does not interfere with mint, fluoride, or active ingredients

Usage rate: 10–30% of toothpaste formula weight.

2. Mouthwash & Oral Rinse

Viscosity builder

• — adds body for improved mouth-coating and longer contact time

Humectant

• — prevents alcohol-based formulas from being overly drying

Sweetness

• — masks bitter actives (chlorhexidine, CPC) without promoting decay

Usage rate: 5–15% of mouthwash formula.

3. Pharmaceutical Tablets — Direct Compression Excipient

Our 20–60 mesh sorbitol powder is optimized for direct compression — the preferred manufacturing method for chewable tablets, lozenges, and effervescent tablets:

Excellent compressibility

• — forms hard tablets at low compression forces

Rapid disintegration

• — tablets dissolve quickly in the mouth or water

Cooling mouthfeel

• — pleasant sensation ideal for throat lozenges and cough drops

Sugar-free

• — suitable for diabetic and pediatric formulations

API compatibility

• — chemically inert with most active pharmaceutical ingredients

No granulation needed

• — direct compression reduces manufacturing steps and cost

Usage rate: 60–95% of tablet weight as the primary filler-binder.

4. Effervescent Tablets

Sorbitol's stability with acid-base systems makes it the excipient of choice for effervescent vitamin, mineral, and analgesic tablets:

Acid-stable

• — no reaction with citric acid during storage

Rapid dissolution

• — dissolves completely within 60 seconds in water

Clean taste

• — no bitter aftertaste masking problem

5. Personal Care & Cosmetics

Sorbitol powder functions as a natural humectant and emollient in personal care products:

Skin moisturizer

• — attracts and retains moisture in creams and lotions (1–5%)

Shampoo & conditioner

• — improves texture and prevents drying (1–3%)

Shaving cream

• — provides glide and post-shave moisture (2–5%)

Bar soap

• — improves transparency in glycerin soaps (3–8%)

6. Syrups & Liquid Formulations

For pharmaceutical syrups, suspensions, and pediatric formulations, sorbitol powder dissolves easily to create sugar-free, non-cariogenic sweetening bases:

Syrup base

• — 70% w/w solution provides viscosity comparable to sucrose syrup

Crystallization resistance

• — prevents cap-lock and crystal growth at bottle neck

Preservative synergy

• — lower water activity reduces preservative load

Formulation Guide

Sorbitol Powder vs. Liquid Sorbitol vs. Glycerol

Quality Assurance

Manufactured in ISO 22000 / HACCP certified facility with full pharmacopoeia compliance:

Identity & Assay

• — HPLC (≥ 99.0%), IR identification

Microbial Limits

• — TAMC ≤ 100 CFU/g, TYMC ≤ 100 CFU/g, pathogens absent (USP <61>/<62>)

Heavy Metals

• — ICP-MS (Pb ≤ 0.5 ppm, As ≤ 2 ppm, Ni ≤ 1 ppm)

Physical

• — Melting point 95–99°C, pH 5.0–7.0, moisture ≤ 1.0%

Residue

• — Sulphated ash ≤ 0.1%, chloride ≤ 50 ppm, sulphate ≤ 100 ppm

Organic Impurities

• — Reducing sugars ≤ 0.3%, total sugars ≤ specified limit

Available documents: USP/BP/EP COA, Specification Sheet, MSDS/SDS, DMF Letter of Access, Non-GMO Statement, Halal/Kosher Certificate, Stability Data, Nitrosamine Risk Assessment.

Our company
Qingdao Golden Grain Chemical Co., Ltd, invested by Golden Grain Group Limited, one professional manufacturer and exporter since 2000, is devoted to supplying products and solutions to food & beverage, medicine, animal feed & nutrition, personal care & household, construction, agriculture.
Golden Grain Group Limited have professional staff, advanced production lines and complete lab equipment, pass GMP, HACCP, ISO, HALAL, KOSHER, BRC, GMP-Free, and other necessary certificates, which ensure our quality to be international standard. For many years' experience, we are exporting our products to more than 60 countries in the world.

"Quality Products", "Efficient Service", Golden Grain Group Limited hope to enter good business cooperation with customers at home and abroad for long.

FAQ

Q: What is the difference between food grade and USP/BP/EP grade sorbitol? A: USP/BP/EP grade undergoes additional purification and stricter microbial controls (≤ 100 CFU/g vs. ≤ 1,000 CFU/g). It meets pharmacopoeia monograph requirements for identity, purity, impurities, and microbial limits — required for pharmaceutical, oral care, and some personal care applications.

Q: Is a  DMF available? A: Yes. A Type III DMF is available and a Letter of Access can be provided for your regulatory submissions (FDA, EMA, etc.).

Q: Can sorbitol powder replace glycerol in my toothpaste formula? A: Yes — partially or fully. Sorbitol provides comparable humectancy at lower cost per active kilogram, with the added benefits of non-cariogenic sweetness and lower stickiness. Many manufacturers use a 50:50 sorbitol:glycerol blend for optimal cost-performance.

Q: Which particle size for direct compression tablets? A: 20–60 mesh. This range provides optimal powder flow, compressibility, and tablet hardness. Fine powder (60–100 mesh) can cause flow issues in high-speed presses.

Q: Does sorbitol powder support "sugar-free" and "tooth-friendly" claims? A: Yes. Sorbitol is non-cariogenic and recognized as safe for teeth by the FDI World Dental Federation. It supports "sugar-free" labeling under FDA, EU, and most global regulations.

Q: Is your sorbitol suitable for halal and kosher pharmaceutical products? A: Yes. All grades are Halal and Kosher certified. Non-GMO statement available.

Q: Can I get a sample and documentation for regulatory filing? A: Yes. Free samples (500 g – 1 kg) with full documentation package: COA, Specification Sheet, MSDS/SDS, DMF Letter of Access, Non-GMO Statement, Halal/Kosher Certificate, Nitrosamine Risk Assessment. Buyer covers courier.

Regulatory or formulation question? Contact us with your monograph requirements (USP/BP/EP) and target application — our technical team will provide the right grade and documentation package.