Active Pharmaceutical Ingredients

Acetylsalicylic acid: Rhodine

How you use it:

Rhodia is a leading manufacturer of acetylsalicylic acid worldwide.
Rhodia provides a set of products and services offering:
Unique capability of dual sourcing through ISO 9001 certified plants of
Saint-Fons (France) and Bangpoo (Thailand)
Complete range of products compliant with current Good Manufacturing
Practices (cGMP) standards
Diversified products from powder to directly compressible granules
Regulatory expertise and efficient technical assistance
Integrated supply chain and dedicated customer service
Strong customer relationships within the pharmaceutical industry
Active Pharmaceutical Ingredient
Granule
Rhodine 3118, 3126
Formulated product
Drum to Hopper
Rhodine 2312, 2316, 2368, 2371
Active Pharmaceutical Ingredient
Powder
Rhodine 3210, 3220
Active Pharmaceutical Ingredient
Crystal
Rhodine 3020, 3025, 3040,
3080, 2020, 2040, 2080
Dry granulation
Sifting
Milling
Total Feed
crystals
% API Typical dosage form Recommended grade Physical Form
Formulated tablets, caplets and capsules Rhodine 3020, 3025, 2020
Formulated tablets or caplets, alone or blended Rhodine 3040, 2040
with other ingredients
Crystal
100% Effervescent tablets, sachets Rhodine 3080, 2080
Soluble, dispersible or effervescent tablets Rhodine 3210, 3220
Powder
and suppositories
Formulated tablets Rhodine 3118, 3126
Granule
(Recommended for high-speed tabletting)
90% Formulated tablets with or without co-actives Rhodine 2312, 2316, 2368, 2371 Drum to hopper granule
How we make it:
Product commercial range:
see also the corresponding Product Data Sheets
Active Pharmaceutical Ingredients
Acetylsalicylic acid: Rhodine

Regulatory:
List of current DMF (Drug Master File) and COS (Certificate Of Suitability):
Formulated grade
Saint Fons plant Bangpoo plant Bangpoo plant
CEP (COS)
US 12092
DMFs for Direct Compressible products are filed
in every country on an as need basis
Please contact our regulatory service department to get DMF numbers
Last audit from
western authorities
FDA - Jan 03 FDA - Jan 04 FDA - Jan 04
DMF US 11373 US 12092
1993-007
Acetylsalicylic acid : Rhodine
100% API
Grade
CAS Number
50-78-2
Molecular weight
180,2 g/mol
Crystallographic structure (X-Ray)
Monoclinic
Stability
Partial hydrolysis may occur when in contact with humid air
Re-test date is 3 years for all grades if the product is stored at or below 25C
Minimum Ignition Energy < 5 mJ
Minimum Ignition concentration: 10 g/m
3
As a bulk product, a face mask, gloves and glasses should be worn when handling
At 25C: 9.6 g/l
At 37C: 17.6 g/l
Melting point
about 136C
(2)
Safety data
Solubility in Water
Acetylsalicylic acid : Rhodine
Physico-chemical properties
(1)
:
(1): other physico-chemical properties (flowability, angle of respose, etc) are very grade-dependant. Please contact our technical service department for further information.
(2): with decomposition
How to contact us:
Europe, Africa, Middle East : +33 4 37 24 88 88 North America : +1 609 860 3891
Asia : +852 2807 5373 Latin America : +55 11 3741 7118
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Active Pharmaceutical Ingredients
Paracetamol / Acetaminophen: Rhodapap
TM
Product commercial range:
see also the corresponding Product Data Sheets
Rhodia is a leading manufacturer of paracetamol/acetaminophen worldwide.
Rhodia provides a set of products and services offering:
Unique capability of dual sourcing through Roussillon (France) and Wuxi
(China) auditable facilities
Complete range of products compliant with current Good Manufacturing
Practices (cGMP) standards
Diversified products from powder to directly compressible granules
Regulatory expertise and efficient technical assistance
Integrated supply chain and dedicated customer service
Strong customer relationships within the pharmaceutical industry
Formulated product
Drum to Hopper *
Rhodapap DC 90 FB, DC 90 Fine,
DC 90 Ultrafine, DC 90 HSP
Active Pharmaceutical Ingredient
Powder
Rhodapap Powder, Dense Powder,
Fine Powder
Active Pharmaceutical Ingredient
Crystal
Rhodapap Crystals, Fine
Crystals
Wet granulation
Sifting
Milling
Total feed
crystals
How we make it:
Formulated product
Directly Compressible
Rhodapap DCP 3, DCP 4
Formulated product
Directly
Compressible
Active Pharmaceutical
Ingredient
Powder
Binder
Filler
Desintegrant
Lubricant
Others
Formulated product
Drum to
Hopper
% API Typical dosage form Recommended grade Physical Form
Rhodapap Crystals
Rhodapap Fine Crystals
Rhodapap Dense Powder
Rhodapap Powder
Syrups, suspensions, suppositories and effervescent
tablets
Rhodapap Fine Powder
97% Rhodapap DCP-3
96% Rhodapap DCP-4
Tablets and caplets Rhodapap DC 90 HSP, DC 90 FB
Multi-active tablets and caplets Rhodapap DC 90 Fine
Multi-active tablets and caplets
(Recommended if content uniformity is a key issue)
Rhodapap DC 90 Ultrafine
Crystal
Tablets and caplets
100%
90%
Taste-masked products, sachets, hard gelatine
capsules
Multi-active tablets and caplets
(Recommended if flexibility in the formulation of the
drug product is needed)
Powder
Directly Compressible
granule
Drum to Hopper
granule
How you use it:
* Drum to Hopper = ready-to-use product
Active Pharmaceutical Ingredients
Paracetamol / Acetaminophen: Rhodapap
TM
Regulatory:
List of current DMF (Drug Master File) and COS (Certificate Of Suitability):
Roussillon
plant
Wuxi
plant
DCP-3 DCP-4
"Drum to Hopper"
grades
CEP (COS)
1992-010 2002-214
US 17745
Last audit from
western authorities
FDA - Apr. 06 FDA - Apr. 05 FDA - Apr. 05
US 17745
Acetaminophen : Rhodapap
Formulated grade 100% API
Grade
DMFs for Direct Compression products are filed in every
country on an as need basis
Please contact our regulatory service department to get DMF
numbers
DMF US 17913
CAS Number 103-90-2
Molecular weight 151,2 g/mol
Crystallographic structure (X-Ray) Monoclinic
Stability
Stable - No special storage conditions are required
Re-test date is 5 years
Minimum Ignition Energy < 5 mJ
Minimum Ignition concentration: 15 g/m
3
As a bulk product, a face mask, gloves and glasses should be worn when handling
At 25C: 3.3 g/l
At 37C: 10 g/l
Melting point
168 - 172C
Safety data
Solubility in Water
Acetaminophen : Rhodapap
Physico-chemical properties: *
* other physico-chemical properties (flowability, angle of respose, etc) are very grade-dependant. Please contact our technical service department for further information.
How to contact us:
Europe, Africa, Middle East : +33 4 37 24 88 88 North America : +1 609 860 3891
Asia : +852 2807 5373 Latin America : +55 11 3741 7118
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Intermediates and Active Pharmaceutical Ingredients
Salicylic acid Methyl salicylate
Salicylic acid and methyl salicylate are offered as intermediates and as active
pharmaceutical ingredients.
Rhodia is producing salicylic acid using world-leading manufacturing technology ensuring
outstanding quality
Rhodia can supply from two production units in France (cGMP) and Brazil (ISO 9001)
Rhodia produces 3 grades of salicylic acid including a USP grade
Rhodia is the only producer of granular salicylic acid (used to reduce dust problems)
Benefiting from our strong position in salicylic acid, Rhodia is able to offer methyl salicylate
and a range of other esters
Product commercial range:
see also the corresponding Product Data Sheets
% API Main pharmaceutical application Industrial application Recommended grade Physical Form
Ointments Salicylic Acid Pharma Crystal
Intermediates for chemical synthesis Salicylic Acid Purified Crystal/Granule
Intermediates for chemical synthesis Salicylic Acid Technical Crystal
100%
Ointments Intermediates for chemical synthesis Methyl salicylate Liquid
SALICYLIC ACID
METHYL SALICYLATE
100%
Intermediates and Active Pharmaceutical Ingredients
Salicylic acid Methyl salicylate
Regulatory:
List of current DMF (Drug Master File) and COS (Certificate Of Suitability):
Salicylic Acid Methyl salicylate
Plant Roussillon and Paulinia Saint-Fons
COS 1993-08 1994-008
US DMF 11232*
Last audit from Western
authorities
FDA - July 97* AFSSAPS - Nov 02
Salicylic Acid Methyl Salicylate
CAS Number 69 - 72 - 7 119-36-8
Molecular weight (g/mol)
138,1 152,1
Crystallographic structure (X-Ray)
Monoclinic Liquid
Stability Stable Stable
Minimum Ignition Energy = 22 mJ Flash point : 96C
Minimum Ignition concentration: 34 g/m
3
As a bulk product, a face mask, gloves and
glasses should be worn when handling
Gloves and appropriate glasses
Solubility in Water At 25C: 2,2 g/l - At 37C: 3,7g/l
Low solubility in water (0.7 g/l at 30C),
soluble in ethanol, acetone, ether
Melting point
158 - 161C -8.6C
Safety data
Physico-chemical properties:
* For Roussillon only
How to contact us:
Europe, Africa, Middle East : +33 4 37 24 88 88 North America : +1 609 860 3891
Asia : +852 2807 5373 Latin America : +55 11 3741 7118
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Active Pharmaceutical Ingredients
Guaiacol Guaifenesin
Rhodia is one of the principal manufacturers of Guaifenesin. It is produced in the Saint-Fons
plant (France) where Rhodia is vertically integrated in guaiacol, further ensuring the products
quality and consistency. The plant adheres to current Good Manufacturing Practices (cGMP) and
has been successfully inspected by various authorities, among them the Food and Drug
Administration (FDA) and the French health agency (AFSSAPS). Rhodia offers :
A unique dual sourcing capability on guaiacol at Saint-Fons (France) and Baton Rouge (USA)
Strong customer relationships with the Pharmaceutical industry
Regulatory expertise and efficient technical assistance
Integrated supply chain and customer service
Product commercial range:
see also the corresponding Product Data Sheets
% API Typical dosage form Recommended grade Physical Form
100%
Tablets Guaiacol pharma Liquid
100%
Syrups, tablets Guaifenesin Crystal
GUAIACOL
GUAIFENESIN
Active Pharmaceutical Ingredients
Guaiacol Guaifenesin
Regulatory:
List of current DMF (Drug Master File) and COS (Certificate Of Suitability):
Guaiacol Guaifenesin
Plant Saint-Fons and Baton Rouge Saint-Fons
CEP (COS) Ph. Eur. Monograph in preparation 1994-007
US DMF 4989
Last audit from
Western
authorities
AFSSAPS - Nov 02
Guaiacol Guaifenesin
CAS Number 90-05-1 93-14-1
Molecular weight (g/mol) 124,14 198,2
Crystallographic structure (X-Ray) Liquid Orthorhombic
Stability
Stable - Avoid contact
with strong oxidizing agents
Stable - Re-test date is 5 year, no special
storage conditions are required
Flash point : 82C Minimum Ignition Energy < 5 mJ
Minimum Ignition concentration: 15 g/m
3
Gloves and appropriate glasses
As a bulk product, a face mask, gloves and
glasses should be worn when handling
Solubility in Water At 30C: 10 g/l At 20C: 50 g/l
Melting point
28C 79 - 83C
Safety data
Physico-chemical properties:
How to contact us:
Europe, Africa, Middle East : +33 4 37 24 88 88 North America : +1 609 860 3891
Asia : +852 2807 5373 Latin America : +55 11 3741 7118
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