The pharmaceutical industry relies significantly on the utilization of Maize Starch Powder. Sahyadri Starch, an FDA-approved manufacturer, produces IP starches in 25 kg PP bags, strictly adhering to FDA guidelines. These IP starches are derived from high-quality maize and are meticulously packaged in a hygienic environment, following stringent GMP practices across the manufacturing process.
Maize Starch Powder finds multiple applications in the pharmaceutical field. It serves as a filler in pills and capsules, ensuring proper dosage and uniformity. Additionally, starch is employed to coat bitter-tasting pills, enhancing patient compliance. IP grade Maize starch powders are particularly valuable in the dry granulation technique, especially when active ingredients exhibit hygroscopic properties, making it challenging to achieve adequate drying after wet binding.
Moreover, Starch Powder proves useful as a tablet binder and disintegrating agent in dispersible tablets, facilitating their dissolution upon administration. To ensure quality control, Sahyadri Starch maintains an in-house microbiology lab equipped with state-of-the-art facilities and competent resources. This enables continuous online monitoring of processing and comprehensive off-line testing, ensuring the consistent production of high-quality starch products that meet stringent pharmaceutical standards.
Parameters | Standards | Method |
---|---|---|
Description | A very fine, white or slightly yellowish powder or irregular white masses which are readily reducible to powder, creaks when pressed between the fingers; odourtess and tasteless. | Visual & sensory inspection |
ldentification A, B, & C | As per IP, for Maize Starch | Visual |
Acidity | Not more than 2.0 ml is required to change the color of the solution | IP Test |
lron (ppm) | 40.0 Max. | IP Test / SPT-20 |
Fluorescence | No fluorescence should be visible under screened ultra- violet light. | IP Test |
Oxidizing substances | No distinct brown or blue colour is observed. | IP Test / SPT-33 |
Sulphated Ash % | Not more than 0.60, determrned on 2.0 g | IP Test / SPT-i9 |
Loss on dryinE % | Not more than 15.0 | SPT-01 |
Microbiological Analysis | ||
Escherichia coli | Absent / gm | |
Salmanella | Absent / 10gm | IP Test / SMBL-07 |
Shigella | Absent / 10gm | |
Additional Tests | ||
Solubility | Practically insoluble in cold water and in Ethanoi (95%) | SPT-05 |
pH of 10 % Aq.Solution | 5,00 - 6 50 | SPT-03 |
Free Sulphur Dioxide (ppm) | 70.0 Max. | SPI-16 |
Sieve Retention % on 150 # | 1.00 Max. | SPT-35 |
Bulk Density (gmlml) | 0.50 Min | SPT.O9 |
Total Plate Count | 1000 cfu/gm (Max.) | |
Yeast & Mouici | 100 cfu/gm (Max.) | SMBL-07 |
Ps. aeruginosa | Absent / gm | |
Staphylococcus aureus | Absent / gm | |
Enterobacteriaceae | Absent / gm |
Expiry date:- 60 months from the date of manufacturing