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Pharma

Our Pharma Product Range:

Magnesium Stearate

Stearic Acid

Refined Glycerine

Calcium Stearate

Magnesium Stearate

3F LuboMag, Magnesium Stearate - IP/BP/USP/Ph.Eur Grade.
Magnesium stearate is one of the most desirable natural flow agents used by pharmaceutical companies as an excipient as it is safe and non-toxic.

3F Advantages:

  • In-house manufacturing of Stearic Acid, the key raw material for complete control over the final quality of Magnesium Stearate.
  • The automated production unit ensures excellent control on various product properties such as Specific Surface Area, Particle Size, and Fatty Acid Composition that correlates with lubricant efficacy. Best-in-class technology to facilitate product customisation as per formulation requirements.
  • In-Line high-efficacy magnetic treatment process, ensures Metal Particle-Free Magnesium Stearate.
  • 3F Magnesium Stearate products comply with all major pharmacopeia: IP, USP, Ph. Eur, BP.
  • All the grades are produced in accordance with strict GMP conditions.
  • TSE / BSE Free product.
  • Consistent compliance to specification for every batch is a hallmark of 3F Magnesium Stearate.

Applications:

  • Pharmaceutical industry, Food, Nutraceutical & Cosmetic formulations as Lubricant, Anti-Adherent, Anti caking agent, Binder, Emulsifier etc.

Packaging:

  • 25 kgs Nett weight packed in Paper Bags/ HDPE Drums with HDPE inner liners.

Product
Specifications:
3F LuboMag
Magnesium Stearate:

Sr.No. Test IP BP Ph.Eur. USP
1 Appearance + + + +
2 Solubility - + + -
3 Identification +
• Freezing point + + + -
• Acid value + + + -
• Fatty acid Composition + - - -
• Assay of Magnesium (on dried basis) + + + +
• Precipitation test - + + -
• Identification A - - - +
• Identification B - - - +
4 Appearance of solution of the fatty acids + - - -
5 Alkalinity or Acidity + + + +
6 Free Stearic Acid + - - -
7 Heavy metals +
• Lead NA + + +
• Cadmium NA + + +
• Nickel NA + + +
8 Impurities
• Sulfates + + + +
• Chlorides + + + +
9 Zinc Stearate + + - -
10 Fatty Acid Composition
• Stearic acid content + + + +
• Palmitic Acid + Stearic acid + + + +
11 LOD at 105 deg C + + + +
12 Specific Surface Area - + + +
13 Microbial Test - + + +

Other best-in-class products available

• 3F LuboCal Calcium Stearate IP/BP/USP/ Ph.Eur
• 3F LuboStear Stearic Acid IP/BP/USP/Ph.Eur.

Refined Glycerine - Pharma Grade

Refined Glycerine is odourless and colourless. Its multi-functional properties and non-toxic nature make it a versatile product which is extensively used in pharmaceutical products, personal care and cosmetics.

3F Advantages:

  • Produced from in-house crude glycerine from vegetable oil & fat-based feedstock.
  • All the grades are produced in accordance with strict GMP conditions.
  • Automated drum filling mechanism.
  • TSE / BSE Free product.

Product Specifications

Product CAS No. Glycerol (%) Refractive Index (at 20 0C) Specific Gravity Heavy Metal (ppm) Chloride (ppm as Cl) Sulfate (ppm as SO4) Water (% w/w)
Glycerine - IP Grade 56-81-5 99.50 Min. 1.470 – 1.475 5 Max. 25 Max. 10 Max. 0.2 Max.
Glycerine - USP Grade 56-81-5 99.50 Min. - 1.249 Min at 250C 5 Max. 10 Max. 10 Max. 0.2 Max.
Glycerine - EP Grade 56-81-5 99.50 Min. 1.470 – 1.475 5 Max. 25 Max. - 0.2 Max.
Glycerine - BP Grade 56-81-5 99.50 Min. 1.470 – 1.475 5 Max. 25 Max. - 0.2 Max.

Application:

Refined Glycerine is used in pharmaceutical industries as lubricant, thickener, demulcent, humectant and sweetener. It is commonly used in expectorants, suppositories and gel capsules.

Packaging: Bulk in Tanker Load / Flexi Tank & 250 Kgs net weight in new HDPE Barrel.

Fortresses for Innovation

3F Pharma Division boasts of state-of-the-art manufacturing unit with leading technologies for continuous innovation and progressive research.

Key Highlights:

  • The state-of-the-art WHO GMP-Standard Facility for production of Pharma Grade Magnesium Stearate, Calcium Stearate, Stearic Acid and Refined Glycerine.
  • Production of different grades for Pharma, Food and Cosmetic applications.
  • Reverse integration with the in-house Key Raw Materials like Stearic Acid and Crude Glycerine to provide complete control over final product quality.
  • Automated production system with precise pneumatic control right from Raw Material Charging Section till Packing Section to ensure product quality well within the specifications and without traceable contamination.
  • Physical attributes of Magnesium Stearate like Specific Surface Area, Particle Size Distribution, Bulk Density and Tap Density are closely monitored and controlled to ensure the best-in-class lubrication property.
  • Fully automated CIP (Cleaning-In-Place) system with 2-stage cleaning process is provided in the processing area to provide a high degree of cleaning and to avoid cross contamination.
  • A dedicated Air Handling Unit provided to each critical area with ISO 8 classified system in processing areas.
  • Purified Water produced by RO with EDI system is used for cleaning of process equipment.
  • Seamless Anti-Static PU flooring in all Clean Room Processing areas and PU flooring in all other processing areas and storage areas.

Q.C. & Q.A. Facilities

  • The Q.C. department is well equipped with WHO GMP-Compliant
    Chemical, Instrumental & Microbiological Laboratory.
  • The laboratory has 21 CFR compliant instruments.
  • Separate Stability Testing Facility and Control Sample Storage area as
    per the latest ICH guidelines.
  • World class QMS (Quality Management System) in place.
    The dynamic QA team assures strict compliance with the regulatory
    requirements.
  • Effective QMS for CAPA, OOS & OOT management.

Certificates & Compliances

  • IP, USP, BP & EP
  • ISO 9001-2015
  • USDMF
  • Certifications in pipeline
    • WHO GMP
    • FSSAI

Manufacturing best-in-class products since 1962.

(Formerly Foods, Fats and Fertilizers)

Corporate Office

6-3-569/2, 4th Floor, Rockdale, Somajiguda, Hyderabad - 500 082.
E: info.pharma@fff.co.in | P: +91 40 4455 7999 | www.fff.co.in

Registered Office: Post Box 15, Tanuku Road, Tadepalligudem, W.G. District – 534101, Andhra Pradesh, India.
P: 91 8818 222571 F: 91 8818 222172

Factory: Survey No. 1604. APIIC-IALA, Epuru, (1B), Pantapalem Village,
Muthukuru Mandal, Sri Potti Sriramulu Nellore District – 524 323, A.P., India.