RanQ Remedies Pvt. Ltd

   
Product Range & Grades
The Future

Product, Grades, Specifications, Typical COA
A) Microcrystalline Cellulose
B) Co processed Excipients

A] Microcrystalline Cellulose (MCC)

All grades of RanQ MCC are Spray Dried and suitable for Direct Compression on High Speed tableting machines. The consistent quality of excipients cannot but be stressed as it constitutes 25 - 80 % of the total weight in a solid dosage formulations. The product quality for MCC starts with the proper specification for wood-pulp. Wood-Pulp is a commodity item in the world market and primarily finds usage in the Rayon industry - the pharmaceutical usage accounting for less then 5% of the total wood-pulp consumption. There are therefore only very few mills in the world which manufacture wood-pulp for pharmaceutical end usage.

RanQ for the last 15 years has standardized its wood-pulp purchases from a single mill in South Africa. The company is the largest manufacturer of dissolving grade pulp in the world. The specific grade of wood-pulp has, low resins content & impurity profile and is certified as suitable for MCC. MCC manufactured from low grade pulp / other sources of cellulose may also meet the pharmacopoeia standards but could have online production failure in tablet – hardness, friability, black specs, weight variation, etc. resulting in re working/ loss of high value API’s. MCC performance is dependent on chemical & physical parameters listed below,
Some of them do not find mention in pharmacopoeias :

  • Degree of Polymerization ( < 350 USP-NF)
  • Conductivity ( < 75 µ USP-NF)
  • Particle size distribution
  • Bulk Density - Tapped / Un-Tapped
  • Flow Properties
  • Loss on Drying
  • Colour

RanQ has its own internal limits and range for the above parameters which ensure CONSISTENT values for tablet formulation in terms of Appearance, Hardness, Compressibility, Friability, Weight Variation, Disintegration time and Dissolution profile.

RanQ MCC is suitable for Direct Compression on High Speed Machines.

MCC -GRADES
SR TEST Specifications / Limits TYPICAL VALUES
     
1 Description A white Crystalline , odourless, tasteless powder complies
2 Solubility Insoluble in water, in dilute HCL 
(22.6 v/v ), in acetone
Practically insoluble in NaOH ( 1 in 20) solution
complies
3 Identification A (Chemical)
Identification B (Degree of Polymerization)

Pass
Between 180 -220 

Pass
212
       
4 pH 5.5 - 7.0 6.1
       
5 Water Soluble Substance NMT 0.16 % w/w 0.14% w/w
       
6 Heavy Metals NMT 0.001% Within limit
       
7 Sol.in Cu. Tetramine Hydroxide Soluble Pass
       
8

Loss on Drying

  • Grades -101 / 102 / 200
  • Grade -  112
 3.0 - 5.0% w/w
 NMT 1.5% w/w
4.2% w/w
1.1% w/w
9 Residue on Ignition   NMT 0.05 % w/w 0.04% w/w
       
10 Ether Soluble Substance NMT 0.05  % w/w 0.02% w/w
       
11 Conductivity NMT 75 microS per cm within limit
12

Bulk Density   - Untapped

  • Grades 102 / 112 / 200
  • Grade   101


 0.28 - 0.34 gm/ml
 0.26 - 0.33 gm/ml
0.32 gm/ml
0.31 gm/ml
13 Particle Size        Grades 102 / 112     
  (a) Retained on 60 mesh NMT 8.0%w/w nil
  (b) Retained on 200 mesh NLT 45.0% w/w 54.4 % w/w
       
  Particle Size        Grade 101    
  (a) Retained on 60 mesh NMT 8.0%w/w nil
  (b) Retained on 200 mesh NMT  30.0% w/w 27% w/w
       
 

Particle Size        Grade 200

   
  (a) Retained on 60 mesh NMT 8.0%w/w nil
  (b) Retained on 200 mesh NLT  70.0% w/w 77%w/w
       
14 Whiteness  % Internal  test NLT 85.0% 86.1%
       
15 Microbial Limits
Total aerobic count
Total mould and yeast count 
Staphylococcus aureus
Pseudomonas aeruginosa
Salmonella
Escherichia coli
NMT 100 cfu /gm
NMT 20 cfu /gm
Absent
Absent
Absent
20 cfu /gm 
10 cfu /gm
Complies
Complies
Complies

 

B] Co-processed Excipients

RanQ has made pioneering efforts in introducing co-processed excipients . Co-processed excipients result in sturdy formulations and achieving complete dry blending of all ingredients and direct compaction for tablet formulations. The elimination of process for Dummy Granulation would result in considerable saving in production costs. The following grades are approved by FDA and are being used commercially by major formulators.

RanExplo - C : MCC + Colloidal Silicon Dioxide + Crospovidone
RanExplo -A : MCC + Colloidal Silicon Dioxide ( Silicified MCC)


Note