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AcnEase® Manufacturing Standards

The AcnEase® formula is protected by trade secrets and the product is manufactured in the USA in an FDA approved facility.

AcnEase® is manufactured in the USA according to GMPs (Good Manufacturing Practices). The herbs are tested extensively (see QC) before being extracted using state of the art equipment. Extracts are boiled for 1 hour 40 minutes; raw materials that are not extracted are hot air sterilized at 140°C for 3 hours. The finished products are then thin coated to minimize taste and facilitate swallowing, and packaged in temper and environment resistant bottles.

QC Summary

All raw materials and final tablets are subjected to rigorous testing according to pharmacopoeial standards. Lists of the assays and results of the QC tests are on file at Herborium.

Raw materials are visually inspected for evidence of mold, rot or any indication that the herbs are not of acceptable quality according to specific SOP's. Each extract is tested for: DDT, Benzex, Arsenic, and Lead. Microbiological testing is performed to check for Colony Forming Units, colibacillus, serratieae, shigella, golden staphylococcus, hemolytic staphylococcus, pathogenic bacteria, mold and yeast.

Tablets are routinely tested according to a predetermined regimen for water, protein, saponin, sugar, reduced sugar, B-Carotene, Vitamin B-2 and total flavones content. The tablets are also tested for hardness, appearance, integrity and dissolution. Stability testing for a minimum of 18 months is also performed on the commercial batches.

 
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