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Pharmaceutical Industries

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Product Description


Titanium Dioxide, Why in Pharmaceutical Industries !

  • It occupies the most Vital Roleand plays an essential Role, from Colouring to Packaging, at all stages of a Pharmaceutical product's Lifecycle.

  • It meets the most stringent of requirements governing thesafety of Medicines, including those set by IP, BP, EP, JP & also USP.

  • It performs a number of Important Functionsthat apply to all stages of a Pharma product's lifecycle,

      From protecting the ingredients,

      To making a Medicine easier to identify or take. 


  • It serves the following functions,

As a Pigment : It is used to add whitenessor accentuate the boldness of other colours. It helps tablets stand out forboth Medical Professionals and Patients, to differentiate the strengths of thesame Medication.

Coatings : It is an essentialcomponent of the Tablet Coating, necessary to preserve the Safety, Efficacy andQuality of the Active Pharmaceutical Ingredient (APIs), and to provideShelf-Life Stability. It offers protection for Photosensitive Ingredients,which could be damaged by visible light, and also offer protection to the APIs/ Ingredients that may be vulnerable to Ultraviolet (UV) light degradation.

Packaging : It is widely used inprotective films for Tablet Strips and Blisters, as well as in externalCartons. This is because of its ability to scatter light and absorb UVrays, means it is routinely incorporated in the packagings of Medicines tomaintain Shelf Life and prevent any Premature Degradation from Moisture, Heator Light. 


Applications : 


It is used in almost all Pharmaceutical Formulation because of itsfollowing characteristics ;

  • It adds Whiteness to Tablets & Capsules.
  • It is used to accentuate the Boldness of other Colours.
  • To differentiate the different strengths of the same Medicines.
  • In the coating it is used to preserve the Safety, Efficacy & Quality ofthe APIs.
  • It also provides Shelf Life Stability.
  • It offers Protection for Photosensitive Ingredients.
  • It is used in packagings of Medicines tomaintain Shelf Life and prevent any Premature Degradation from Moisture, Heat or Light.

Examples : Tablets, Capsules,Pharma Pellets, Empty Hard Gelatin Capsule (EHGC), Ointments, Medical StickyTapes & Packagings like Strips & Blisters etc.


Ultra Pure Product, Heavy Metals Contents, BLQ

[Tested by Independent ProfessionalTesting Laboratory, NABL & FSSAI approved  (By one Lab.)]


Sr.

No.

Parameters

 

Units

Results of Analysis

Limits as per FCC

1

Lead

mg/kg

BLQ

Max. 10

2

Cadmium

mg/kg

BLQ

Not Specified

3

Copper

mg/kg

BLQ

Not Specified

4

Arsenic

mg/kg

BLQ

Max. 1

5

Tin

mg/kg

BLQ

Not Specified

6

Methyl Mercury as Mercury

 

mg/kg

BLQ

Not Specified

7

Mercury

mg/kg

BLQ

Max. 1


BLQ - Below Limit of Quantification

LOQ (Limit of Quantification) for Heavy Metals =0.5mg/kg

FCC : Food Chemical Codex


Heavy Metals Contents & Other CriticalParameters, Tested by Independent Professional Testing Laboratory, NABL &FSSAI approved  (By Theother Lab.)

Sr.

No.

Test Parameters

 

Test Results

Specification

1

Loss on Drying

0.31%

NMT 0.5%

2

Loss on Ignition

0.26%

NMT 1.0%

3

Water Soluble Substance

0.17%

NMT 0.5%

4

Acid Soluble Substance

0.31%

NMT 0.5%

5

Lead

Not Detected

NMT 10.0 mg/kg

6

Cadmium

 

Not Detected

NMT 1.0 mg/kg

7

Mercury

Not Detected

NMT 1.0 mg/kg

8

Arsenic

Not Detected

NMT 1.0 mg/kg

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