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Tartaric acid pellets
16805
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100% Tartaric Acid Pellets are inert cores made following Good Manufacturing Practices
for bulk pharmaceutical excipients

100% TARTARIC ACID PELLETS

Inert Microgranules made of pharmaceutical grade, 100% natural tartaric acid

Application
Tartaric acid is useful in pellets form as inert core for the manufacturing of Pharmaceutical Ingredients in order to improve the solubility of weakly basic drugs.

 

Project Design

  • Surface: roughness and sphericity to ensure uniform application; no porosity, cracks or holes;
  • Reproducibility: Reliable and reproducible uniformity for batch-to-batch consistency;
  • Different Particle sizes: for different pharmaceutical dosages;
  • Minimum humidity content;
  • Low friability and hardness to withstand fluid bed processing;

Product Specifications

SURINERTS – 100 % TARTARIC ACID PELLETS

Tartaric Acid pellets are made for pharmaceutical use

Drug Master File N.: 32545 – Active IV

Composition: (C4,H6,O6) 100%

Size: Available in standard and special sizes (from 300 µm  to 1000 µm ). Other sizes could be customized.

IPS guarantees, for any available size PSD ≥ 90 %

Friability: < 1.0%

Stability: 3 years in monitored conditions

Available Sizes

Quality

Quality is our main concern. Surinerts® products are fully in compliance with: USP and EP current editions. Certificates of Analysis are issued by our Quality Control and approved by our Quality Assurance.

 

We are able to guarantee high quality standards thanks to our severe quality controls, both analytical and microbiological, performed during the entire production process.

 

In-process controls are performed throughout all manufacturing steps. All the analytical tests are carried out both by an internal Analytical Laboratory and by external validated laboratories.

Technical Documentation

Our pellets have been registered by FDA. 100% Tartaric Acid DMF has been filed with number: 32545.

 

All product batches are released with a Certificate of Analysis reporting all the Chemical and Microbiological results.

 

A complete Regulatory Data Sheet is available for 100% Tartaric Acid.