Protection of Light Sensitive Products : Pharmaguideline

Online GMP Courses with Certificate

ENROLL

Protection of Light Sensitive Products

It is important to protect the light sensitive products from direct light. Brown colored light can help to protect the products during manufacturing.
A lot of pharmaceutical products are light sensitive those degrade when directly exposed to the light. Some impurities may develop during this degradation and product may fail during the quality control analysis. These impurities may harm the patient’s health.

These light-sensitive APIs and pharmaceutical products should be protected from light during processing and distribution. Light sensitive products may be affected by sunlight or artificial light. 

Light for light sensitive products
Light induces the interaction between the molecules of the compound that leads to the formation of a new compound known as an impurity. 

Light has energy that can activate the molecules of the drug. Photodegradation usually occurs due to absorption of short wavelength light between 500 and 300 nm. Visible blue, violet and ultraviolet light cause this degradation. For example, ofloxacin remains 80% when exposed to direct light for a period of 240 hours.


List of light sensitive products:

List of light sensitive drugs

Some drugs are affected by light of a special wavelength that should be studied before developing the formulation and product should be protected from that light. Excipients added in the formulation can also reduce the effect of light on a light-sensitive drug. The formulation should be tested for photostability to determine the effect of light on formulated product and to develop the protective measures.


During the manufacturing process, these product should be protected from these light degradation. Lights having a long wavelength (more than 500 nm) are used in granulation, compression and packing areas. Brown colored light having a wavelength between 500 nm and 800 nm is the best option for this purpose.

Tablets containing light-sensitive products should be coated with a colored film coating. It will protect the sensitive drug from degradation due to the light. These tablets should be packed in alu-alu packing or in amber colored blisters. Injections containing light-sensitive drugs should be filled in amber colored vials or containers.

Analysis of light-sensitive products should be done carefully because light may cause an error in the analytical results. Sample preparation should be done in amber colored glassware and also wrapped with aluminum foil when stored. The analysis should be done in dark or brown colored light.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


4 comments: Post Yours! Read Comment Policy ▼

  1. thanks for clarifications

    ReplyDelete
  2. Is linezolid infusion sensitive to room light( electric light)?

    ReplyDelete
    Replies
    1. Yes it is light sensitive and changes its colour when exposed to sunlight or even room light

      Delete

Please don't spam. Comments having links would not be published.


Popular Categories

QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters Education B.Pharmacy
Online Courses


Follow Pharmaguideline


DOCUMENTS

PHARMACEUTICAL DOCUMENTS




Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...

View


adsbypg


Recent Posts