Bismuth Subsalicylate

Product Overview

Bismuth Subsalicylate (C7H5BiO4) is an active pharmaceutical ingredient (API) utilized in gastrointestinal formulations. It operates locally within the digestive tract to inhibit mucosal inflammation, bind bacterial toxins, and suppress Helicobacter pylori proliferation. Produced as an odorless, white to off-white crystalline powder, it serves as the core raw material for oral liquid suspensions, chewable tablets, and solid-dose therapeutic products.

Bismuth Subsalicylate Tablet

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Grades / Types & Specifications

Grade	Primary Formulation Use	Particle Size (D90)	Bulk Density
Pharma Grade	Oral suspensions & standard tablets	< 45 um	0.45 - 0.65 g/cm3
Direct Compression (DC) Grade	High-speed rotary tableting lines	80 - 120 um	0.55 - 0.75 g/cm3
Fine Chemical Grade	Veterinary anti-secretory agents	< 75 um	0.40 - 0.60 g/cm3

Key Properties & Features

01/

Assay Range: 56.0% to 59.0% calculated on the dried basis.

02/

Solubility Profile: Practically insoluble in water and ethanol; soluble in dilute alkali solutions with concurrent decomposition.

03/

Crystalline Phase: Monoclinic crystal system verified via X-ray powder diffraction (XRPD) to ensure consistent dissolution kinetics.

04/

Flowability: Repose angle <= 32 degrees for DC grades, formulated for direct compression without excessive auxiliary excipients.

Applications

Gastrointestinal Therapeutics

Active component for medications managing traveler's diarrhea, acute gastroenteritis, nausea, and dyspepsia.

Eradication Regimens

Ingredient in multi-drug protocols targeting Helicobacter pylori peptic ulcer disease.

Veterinary Therapeutics

Anti-secretory agent integrated into companion animal gastrointestinal care products.

Technical Specifications

Identification: Positive response for Bismuth and Salicylic Acid per standard identification tests.

Loss on Drying: <= 2.0% (determined at 105 degrees C for 3 hours).

Elemental Impurities: Arsenic (<= 2 ppm), Lead (<= 5 ppm), Silver (<= 25 ppm), Copper (<= 25 ppm).

Free Salicylic Acid: <= 0.5%.

Microbial Limits: Total aerobic microbial count <= 10^3 CFU/g; total yeasts and molds <= 10^2 CFU/g; absence of E. coli and Salmonella.

Manufacturing & Quality Control

Synthesis Method

Controlled liquid-phase precipitation reaction combining purified bismuth oxide and salicylic acid under monitored exothermic parameters.

Equipment & Purity

Multi-stage countercurrent washing systems fabricated entirely from 316L stainless steel to prevent ionic leaching and metallic contamination.

Micronization Process

Jet milling systems operated under nitrogen shielding to achieve tight particle size distribution (D10, D50, D90) without thermal degradation.

Batch Testing Protocol

Each commercial lot verified via ICP-MS for heavy metals, HPLC for free salicylic acid degradation, and laser diffraction for particle size distribution.

Packaging & Supply

Primary Container

Double-layer food- and pharma-grade low-density polyethylene (LDPE) bags, heat-sealed under a continuous nitrogen purge.

Secondary Container

25 kg net weight fiber drums equipped with tamper-evident security locking rings.

Storage Parameters

Store below 30 degrees C in a dry, well-ventilated area, isolated from direct sunlight and atmospheric moisture.

Shelf Life

36 months from the date of manufacture when maintained in original, unopened containers.

Customization & OEM

Customized particle size milling (D90 adjusted between 15 um and 150 um) to match client dissolution and suspension settling profiles.

Specialized bulk density tuning for dedicated high-speed direct-compression tableting equipment.

Alternative packaging configurations, including 50 kg fiber drums or foil-lined FIBC bulk containers for high-volume manufacturing facilities.

Frequently Asked Questions

Q: What technical documentation is supplied with commercial orders?

A: A batch-specific Certificate of Analysis (CoA), Safety Data Sheet (SDS), residual solvent declaration, and heavy metal impurity test reports are provided during customer evaluation.

Q: How does particle size selection affect downstream manufacturing?

A: Finer grades (D90 < 45 um) enhance oral suspension stability and dissolution velocity, while coarser grades (80 to 120 um) offer optimal flowability to prevent tablet capping and lamination during high-speed compression.

Q: What is the standard minimum order quantity (MOQ) for commercial procurement?

A: The standard commercial MOQ is 100 kg, packed in four 25 kg fiber drums. 1 kg sample quantities are available for laboratory evaluation and analytical method validation.

Q: How are heavy metal levels controlled during active synthesis?

A: Raw inputs undergo pre-batch screening via ICP-MS. Synthesis utilizes deionized water treated through continuous reverse osmosis and electrodeionization (RO-EDI).

Q: Is production segregated from potential cross-contaminants?

A: Synthesis takes place in a dedicated chemical facility physically isolated from beta-lactam and cytotoxic production lines to eliminate cross-contamination risks.

Q: What is the standard lead time for scheduled purchase orders?

A: Standard inventory ships within 7 to 10 business days following contract confirmation. Custom micronization requirements add 5 business days for processing and quality clearance.

With abundant experience, we are one of the most reliable bismuth subsalicylate manufacturers and suppliers in China. We warmly welcome you to buy customized bismuth subsalicylate made in China here from our factory. If you have any enquiry about free sample, please feel free to email us.

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