Sanitizer formulations and Quality control
- Post By : Kumar Jeetendra
- Source: Microbioz India
- Date: 16 Jun,2020
Sanitizing is most important than anything to protect ourselves in this global pandemic situation. In this current Pandemic situation of COVID-19 it has made every one use hand sanitizer to get rid of any bit of virus present on our hands due to direct or indirect contact with infected one. According to WHO guidelines washing hands every 2 hours or timely sanitizing them to protect her/himself. Now washing hands on the go is not possible for everyone, hence the use of hand sanitizer has been recommended.
While the world strives to cope with a global pandemic, the requirement of hand sanitizers has increased. FDA is allowing additional companies to manufacture alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency, But provided the following circumstances are present:
1. The hand sanitizer is manufactured using only the following United States Pharmacopeia (USP) grade ingredients, consistent with World Health Organization (WHO)recommendations:
a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%,volume/volume (v/v)) in an aqueous solution or Isopropyl Alcohol (75%,v/v) in an aqueous solution.
b. Glycerol (1.45% v/v).
c. Hydrogen peroxide (0.125% v/v).
d. Sterile distilled water or boiled cold water.
WHO recommends the local production of the following two formulations as an alternative when suitable commercial products are either unavailable or too costly, the formulations are as follows.
Quality-control pre and post production is also very important. Pre-production analysis should be made every time an analysis certificate is not available to guarantee the concentration of alcohol. Verify the alcohol concentration with the alcohol meter and make the necessary adjustments in volume in the preparation formulation to obtain the final result.
Post-production analysis is mandatory if either ethanol or an isopropanol solution is used. Use the alcohol meter to control the alcohol concentration of the final use solution. The accepted limits should be fixed to ± 5% of the target concentration (75%–85% for ethanol).
Pre-production reagents quality can be verified in conformity of the respective monograph if an analysis certificate is not available. Density, Refractometry and Titration instrumentation are used to ensure compliance with pharmacopoeia requirements (e.g. European Pharmacopoeia).
• Ethanol 96%: alcoholometry or relative density 0.805 to 0.812 and R.I. 1.3636
• Isopropyl alcohol 99.8%: relative density 0.785 to 0.789 and R.I. 1.376 to 1.379
• Glycerol 98%: refractive index 1.470 to 1.475
• Hydrogen peroxide 3%: concentration can be determined by titration (oxidation of hydrogen peroxide using potassium permanganate).
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