Finar Pharmaceutical Formulations

Finar for

Healthy Living

Excipients for Pharmaceutical formulations

About us Finar Limited has a state of the art manufacturing facility situated at Ahmedabad, India to manufacture high quality Excipients & Pharma grade ingredients. The facility is GMP certified. We have been successfully audited by several domestic as well as international pharma majors and qualified to offer Key Excipients & ingredients for Pharma Formulations especially future generics aimed at regulated markets as well as emerging markets.

In a challenging industry scenario with an escalating requirement on compliance & regulations, Finar deploys several innovative initiatives to meet customer requirements in record time from product development to regulatory authority filing & approvals.

Mission To delight our Customers, Stakeholders & Employees by consistently manufacturing high quality products through Innovation, Research and Development and by maintaining Global best practices in Quality standards and Safety.

Vision To be the market leader in the “Pharmaceutical excipients & Fine Chemicals domain” with a Global perspective by exceeding Customer expectations in Quality and Service, attain operational excellence in Manufacturing, Total Quality Management, Safety & Supply Chain facilitated through our fully compliant state-of-the-art manufacturing plant.

Our Core Values • • • • •

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Integrity Customer First Commitment Respect for Individual Contribute to the Society

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Our Pharma capabilities at a glance Comprehensive Portfolio • • • • •

114+ high quality excipients Pharma grade solvents Excipients for various dosage forms Excipients for injectable formulations including complex injectables DMF filed excipients with US and China

Uncompromised Quality • EXCiPACT certified • State of the art Manufacturing facility (GMP Certified) • ISO 9001:2015, ISO 14001:2015 & OHSAS 18001:2007 certified • ISO 17025 (NABL) accredited fully equipped Quality Control Lab with complete instrumentation as well as Microbial Testing facility • Highly experienced team of Production, Quality Control and Quality Assurance • Dedicated team for Regulatory Affairs

Customer Satisfaction • • • • •

Total support from R&D stage upto Commercial manufacturing Exhibit batches validation support Analytical support through Method validation & protocols Quick deliveries for new projects Dedicated customer support team

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Regulatory Support • • • • • • • • • • • •

Residual Solvent Certificate as per ICH Q3C guidelines Elemental Impurities Certificate as per ICH Q3D guidelines TSE/BSE free Certificate GMO Certificate Latex/Gluten/Melamine/Allergen free Certificate Stability data Analytical Method Validation DMF Filing Free from Genotoxic impurities Quality Compliance Customer Audits Vendor Qualification Documents Well defined & ready to submit • Customer VQ formats also supported • CTD Dossier Preparation & much more...

Visit us at : www.finarchemicaIs.com Write to us at : excipients@finarchemicals.com

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Content Excipients for injectable formulations

6

DMF filed excipients with US and China

8

Excipients developed for specific formulations

9

Pharma grade solvents

10

Excipients exclusively developed for Transdermal patches

11

Excipients for solid/semi-solid dosage forms

12

Other excipients

16

Appendix

17

5

Excipients for Injectable Formulations Several excipients have been developed exclusively for use in injectable formulations. These excipients maintain low level of endotoxins with the bioburden limits (BET/MLT etc) controlled as a part of specifications.

The metallic impurities are also controlled to suit the application.

6

CASR No.

Product Name

Pharmacopoeia / DMF

BET Test Limit

MLT Test (TAMC) Limit

64-19-7

Acetic acid glacial (for haemodialysis)

USP, Ph.Eur, BP, IP, JP

0.5 EU/mg

100 cfu/ml

67-64-1

Acetone

USP-NF, Ph.Eur, BP, CDMF

2.0 EU/ml

100 cfu/ml

75-05-8

Acetonitrile

USDMF, CDMF

2.5 EU/ml

100 cfu/ml

8001-54-5

Benzalkonium chloride 50% Solution

USP-NF, Ph.Eur, IP, BP

0.5 EU/mg

1000 cfu/ml

98-11-3

Benzene sulphonic acid

USDMF, CDMF

2.5 EU/mg

100 cfu/g

65-85-0

Benzoic acid

USP, Ph.Eur, IP

2.5 EU/g

100 cfu/g

100-51-6

Benzyl alcohol

USP-NF, Ph.Eur, BP, IP

2.5 EU/ml

100 cfu/ml

120-51-4

Benzyl benzoate

USP, Ph.Eur, BP, IP, CDMF

0.25 EU/ml

100 cfu/ml

128-37-0

Butylated hydroxytoluene

USP-NF, Ph.Eur, IP, CDMF

0.5 EU/mg

100 cfu/g

10035-04-8

Calcium chloride

USP, Ph.Eur, IP

2.5 EU/g

100 cfu/g

5793-89-5

Calcium saccharate

USP

5.0 EU/g

1000 cfu/g

77-92-9

Citric acid anhydrous

USP, Ph.Eur, IP

0.5 EU/mg

100 cfu/g

60-27-5

Creatinine

USP-NF

2.5 EU/g

100 cfu/g

110-97-4

Diisopropanolamine

USP

2.5 EU/ml

100cfu/ml

7558-79-4

di-Sodium hydrogen o-phosphate anhydrous

USP, Ph.Eur, BP

2.5 EU/g

100 cfu/g

7782-85-6

di-Sodium hydrogen o-phosphate heptahydrate

USP

2.5 EU/mg

100 cfu/g

10039-32-4

di-Sodium hydrogen o-phosphate dodecahydrate

IP, BP, USP, Ph.Eur

2.5 EU/g

1000 cfu/g

6106-21-4

di-Sodium succinate hexahydrate

USDMF, USP-NF, CDMF

6.0 EU/g

100 cfu/g

111-42-2

Diethanolamine

USP-NF, IP

2.5 EU/ml

100 cfu/ml

67-68-5

Dimethyl sulphoxide

USP, Ph.Eur

-

1000cfu/ml

6381-92-6

EDTA di-sodium salt dihydrate

USP, Ph.Eur, IP

30 EU/g

1000 cfu/g

56-81-5

Glycerin

USP/Ph.Eur

5.0 EU/g

100 cfu/g

50-81-7

L(+)Ascorbic acid

USP, Ph.Eur, IP

1.2 EU/g

1000 cfu/g

79-33-4

L-(+)-Lactic acid

USP-NF, BP, IP, JP

5.0 EU/g

108-95-2

Liquefied Phenol

USP

0.2 EU/mg

100 cfu/ml

7791-18-6

Magnesium chloride hexahydrate

USP, Ph.Eur, BP, IP

2.5 EU/g

100 cfu/g

108-39-4

meta-Cresol

USP, Ph.Eur, BP, CDMF

0.5 EU/mg

75-75-2

Methane sulphonic acid

USDMF, CDMF

0.5 EU/mg

100 cfu/ml

96-27-5

Monothioglycerol

USP-NF, IP, CDMF

6.0 EU/ml

100 cfu/ml

127-19-5

N,N-Dimethyl acetamide

USDMF, Ph.Eur, CDMF

2.0 EU/ml

100 cfu/ml

872-50-4

N-Methyl 2-pyrrolidone

USP-NF, Ph.Eur

2.5 EU/ml

100cfu/ml

108-95-2

Phenol

USP, Ph.Eur, IP

0.2 EU/mg

1000 cfu/ml

25322-68-3

Polyethylene glycol 400

USP-NF, Ph.Eur

2.5 EU/ml

100 cfu/ml

7447-40-7

Potassium chloride

USP, Ph.Eur, BP, IP

2.5 EU/g

100 cfu/g

7778-77-0

Potassium di-hydrogen ortho-phosphate

USP-NF, Ph.Eur

2.5 EU/mg

100cfu/g

57-55-6

Propylene glycol

USP, Ph.Eur, BP, IP

0.25 EU/ml

100 cfu/ml

6131-90-4

Sodium acetate trihydrate

USP, Ph.Eur , IP, BP

0.5 EU/mg

100 cfu/g

532-32-1

Sodium benzoate

USP-NF, Ph.Eur, BP, IP

2.5 EU/g

100 cfu/g

7631-90-5

Sodium bisulfite

JP

6.0 EU/g

100 cfu/g

7647-14-5

Sodium chloride

USP, Ph.Eur, BP, IP

5.0 EU/g

100 cfu/g

7558-80-7

Sodium di-hydrogen o-phosphate anhydrous

USP, BP, IP

2.5 EU/g

100 cfu/g

7681-57-4

Sodium metabisulphite

USP-NF, Ph.Eur, IP

6.0 EU/g

100 cfu/g

7757-83-7

Sodium sulfite anhydrous

USP-NF, Ph.Eur

2.5 EU/mg

100 cfu/g

6106-24-7

Sodium Tartrate

USP-NF

2.5 EU/g

100 cfu/g

110-15-6

Succinic acid

USP-NF

2.5 EU/g

100 cfu/g

75-65-0

tert - Butanol

USDMF, CDMF

6.0 EU/ml

100 cfu/ml

6132-04-3

tri-Sodium citrate dihydrate

USP, Ph.Eur, IP

2.5 EU/g

102-71-6

Trolamine (Triethanolamine)

USP-NF, Ph.Eur

0.5 EU/mg

100 cfu/ml

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MLT Test (TYMC) Limit

Buffering Agents/ pH modifiers

Tonicity Adjusting agents

Antimicrobial/ Preservative

Bulking agents

Solvents/ Co-Solvents

Chelating Agents

Antioxidants and Reducing Agents

Stabilizer

100 cfu/ml 10 cfu/ml

•

10 cfu/ml

•

100 cfu/ml 10 cfu/g

• •

10 cfu/g

•

100 cfu/ml

•

10 cfu/ml

•

10 cfu/g

•

10 cfu/g

•

100 cfu/g 10 cfu/g

• •

10 cfu/g

•

100cfu/ml

•

10 cfu/g

•

10 cfu/g

•

100 cfu/g

•

50 cfu/g

•

10 cfu/ml

• •

100cfu/ml 100 cfu/g 10 cfu/g

• •

•

100 cfu/g

•

•

• 100 cfu/ml

•

10 cfu/g

• •

100 cfu/ml

•

10 cfu/ml

•

10 cfu/ml

•

10 cfu/ml

•

1000 cfu/ml

•

10 cfu/ml

•

10 cfu/g 10 cfu/g

• •

10 cfu/ml 10 cfu/g

• •

10 cfu/g

•

100 cfu/g

•

10 cfu/g 10 cfu/g

•

• •

10 cfu/g

•

10 cfu/g

•

10 cfu/g

•

10 cfu/g

•

100 cfu/ml

•

• •

10 cfu/ml

•

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DMF Filed Excipients Finar has exclusively developed several excipients with Type IV DMF filing with US FDA & China CDE with National Medical Products Administration (NMPA) for use in various drug formulations that are intended for NDA / ANDA filing. Complete regulatory documentation support, open part of DMF & Letter of Access (LOA) can be issued to customers.

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CAS No.

Product Name

US DMF No.

China DMF No.

67-64-1

Acetone

-

CDE # F20200000009

75-05-8

Acetonitrile

DMF # 26612

CDE # F20200000271

98-11-3

Benzene sulphonic acid

DMF # 30281

CDE # F20180001463

120-51-4

Benzyl benzoate

-

CDE # F20190000461

25013-16-5

Butylated hydroxyanisole

-

CDE # F20200000188

128-37-0

Butylated hydroxytoluene

-

CDE # F20200000189

5793-89-5

Calcium saccharate

-

CDE # F20200000092

60-27-5

Creatinine

-

CDE # F20200000002

110-82-7

Cyclohexane

DMF # 26698

-

6106-21-4

di - Sodium succinate hexahydrate

DMF # 31178

CDE # F20200000141

110-17-8

Fumaric acid

-

CDE # F20200000212

67-63-0

Isopropyl alcohol (IPA)

-

CDE # F20200000106

6283-92-7

Lauryl lactate

DMF # 31766

CDE under filing

123-76-2

Levulinic acid

DMF # 31434

CDE # F20190000626

108-39-4

meta-Cresol

-

CDE # F20190000234

75-75-2

Methane sulphonic acid

DMF # 32834

CDE # F20190000136

75-09-2

Methylene chloride (Dichloromethane)

-

CDE # F20200000329

50610-34-9

Monosodium glycine carbonate

DMF # 26697

-

96-27-5

Monothioglycerol

-

CDE # F20180001740

127-19-5

N,N-Dimethyl acetamide

DMF # 26702

CDE # F20190000639

142-82-5

n-Heptane

DMF # 30536

CDE under filing

87-69-4

Tartaric acid

-

CDE # F20200000007

75-65-0

tert-Butanol

DMF # 24710

CDE # F20180001596

78-10-4

Tetraethyl orthosilicate

DMF # 34762

-

100-51-6

Benzyl alcohol

-

CDE under filing

56-81-5

Glycerin

-

CDE under filing

67-56-1

Methyl alcohol

-

CDE under filing

57-55-6

Propylene glycol

-

CDE under filing

7681-57-4

Sodium metabisulphite

-

CDE under filing

110-15-6

Succinic acid

-

CDE under filing

77-93-0

Triethyl citrate

-

CDE under filing

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Excipients Developed for Specific Formulations Certain excipients have been exclusively developed for a few drug formulations that would go off-patent in the coming years. These excipients are Type IV DMF filed with USFDA & CHINA NMPA to aid to the NDA / ANDA filing planned by the drug formulators.

Drug Formulation

Excipient offered by Finar

Regulatory Status/Grade

Amphoterecin B

di-Sodium succinate hexahydrate HP

USDMF, CDMF

tert-Butanol HP

USDMF, CDMF

Acetonitrile HP

USDMF, CDMF

Acetone

USP-NF, Ph.Eur, BP, CDMF

Acetonitrile HP

USDMF, CDMF

tert-Butanol HP

USDMF, CDMF

Levulinic acid

USDMF, CDMF

N,N-Dimethyl acetamide HP

USDMF, Ph.Eur, CDMF

PEG 400

USP, Ph.Eur

Carmustine

tert-Butanol HP

USDMF, CDMF

Cisatracurium besilate (Nimbex)

Benzene sulphonic acid HP

USDMF, CDMF

Cyclophosphamide

tert-Butanol HP

USDMF, CDMF

Decitabine

Acetonitrile HP

USDMF, CDMF

Dihydroergotamine

Methane sulphonic acid

USDMF, CDMF

Dimethyl fumarate

Fumaric acid

CDMF

Doxorubicin

tert-Butanol HP

USDMF, CDMF

Gadopentate dimeglumine

Diethylene triamine pentaacetic acid (Pentetic acid)

USP

Octreotide acetate

n-Heptane HP

USDMF

Octreotide capsule

Sodium caprate

Excipient Grade

Para-Effervescent tablets (Paracetamol)

Monosodium glycine carbonate

USDMF

Teriparatide

meta-Cresol

USP, Ph.Eur, BP, CDMF

Bendamustine

Bortezomib

Buprenorphine patch

Busalfan

* API ingredient

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Pharma Grade Solvents Finar offers highly pure Pharma grade solvents typically used but not limited to several oral solid dosage formulations with a strong control on all possible impurities along with ICH Q3D compliance for R&D to commercial manufacturing.

CASR No.

Product Name

Pharmacopoeia / DMF

67-64-1

Acetone

USP-NF, Ph.Eur, BP, CDMF

100-51-6

Benzyl alcohol

USP-NF, Ph.Eur, BP, IP

120-51-4

Benzyl benzoate

USP, Ph.Eur, BP, IP, CDMF

84-74-2

Dibutyl phthalate

USP-NF, Ph.Eur, BP

84-66-2

Diethyl phthalate

USP, Ph.Eur, IP

67-68-5

Dimethyl sulphoxide

USP, Ph.Eur

141-78-6

Ethyl acetate

USP-NF, Ph.Eur

56-81-5

Glycerin

USP, Ph.Eur, BP, IP, JP

56-81-5

Glycerol 85%

Ph.Eur

107-41-5

Hexylene glycol

USP-NF

67-63-0

lsopropyl alcohol (IPA)

USP, Ph.Eur, BP, IP, JP, CDMF

67-56-1

Methyl alcohol (Methanol)

USP-NF, Ph.Eur, BP, CDMF

75-09-2

Methylene chloride (Dichloromethane)

USP-NF, Ph.Eur, BP, CDMF

71-36-3

n-Butyl alcohol

USP-NF

872-50-4

N-Methyl-2-pyrrolidone

USP-NF, Ph.Eur

25322-68-3

Polyethylene glycol 400

USP-NF, Ph.Eur

108-32-7

Propylene carbonate

USP-NF

57-55-6

Propylene glycol

USP, Ph.Eur, BP, IP

102-76-1

Triacetin

USP, Ph.Eur

77-93-0

Triethyl citrate

USP-NF, Ph.Eur, IP

10

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Excipients Exclusively Developed for Transdermal Patches Finar offers several excipients especially permeation enhancers for Transdermal drug delivery system also known as “Patches”. These excipients demonstrate superior performance offering enhanced skin permeation thereby improving the drug efficacy.

Permeation Enhancers (Solvents) CASR No.

Product Name

Pharmacopoeia / DMF

68-12-2

Dimethyl formamide

USP

67-68-5

Dimethyl sulphoxide

USP, Ph.Eur

56-81-5

Glycerol 85%

Ph.Eur

67-56-1

Methyl alcohol (Methanol)

USP-NF, Ph.Eur, BP, CDMF

57-55-6

Propylene glycol

USP, Ph.Eur, BP, IP

Permeation Enhancers (Surfactants) CASR No.

Product Name

Pharmacopoeia / DMF

5306-85-4

Dimethyl isosorbide

Excipient grade

577-11-7

Dioctyl sodium sulphosuccinate (DOSS) (Monoxal OT)

USP, Ph.Eur

107-41-5

Hexylene glycol

USP-NF

6283-92-7

Lauryl lactate

USDMF

CASR No.

Product Name

Pharmacopoeia / DMF

123-76-2

Levulinic acid

USDMF, CDMF

57-13-6

Urea

USP, Ph.Eur, BP, IP

Other Excipients

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Excipients for Solid/Semi-solid Dosage Forms Excipients specially developed for solid and semi-solid dosage forms to perform certain functional roles in the formulations.

CASR No.

Product Name

Pharmacopoeia / DMF

67-64-1

Acetone

USP-NF, Ph.Eur, BP, CDMF

8001-54-5

Benzalkonium chloride 50% solution

USP-NF, Ph.Eur, IP, BP

121-54-0

Benzethonium chloride

USP, Ph.Eur

65-85-0

Benzoic acid

USP, Ph.Eur, IP

100-51-6

Benzyl alcohol

USP-NF, Ph.Eur, BP, IP

120-51-4

Benzyl benzoate

USP, Ph.Eur, BP, IP, CDMF

25013-16-5

Butylated hydroxyanisole

USP-NF, Ph.Eur, CDMF

128-37-0

Butylated hydroxytoluene

USP-NF, Ph.Eur, IP, CDMF

62-54-4

Calcium acetate

USP

471-34-1

Calcium carbonate

USP, Ph.Eur, BP, IP

77-92-9

Citric acid anhydrous

USP, Ph.Eur, IP

5949-29-1

Citric acid monohydrate

USP, Ph.Eur, BP, IP

60-27-5

Creatinine

USP-NF

84-74-2

Dibutyl phthalate

USP-NF, Ph.Eur, BP

111-42-2

Diethanolamine

USP-NF, IP

84-66-2

Diethyl phthalate

USP, Ph.Eur, IP

5306-85-4

Dimethyl isosorbide

Excipient grade

577-11-7

Dioctyl sodium sulphosuccinate (DOSS) (Monoxal OT)

USP, Ph.Eur

50-00-0

Formaldehyde

USP, Ph.Eur, BP

Diluents/ Fillers

Bulking agents

•

•

23411-34-9

EDTA calcium disodium

USP

6381-92-6

EDTA di-sodium salt dihydrate

USP, Ph.Eur, IP

110-17-8

Fumaric acid

USP-NF, IP, CDMF

56-81-5

Glycerin

USP, Ph.Eur, BP, IP, JP

56-81-5

Glycerol 85%

Ph.Eur

56-40-6

Glycine

IP, Excipient grade

107-41-5

Hexylene glycol

USP-NF

67-63-0

Isopropyl alcohol (IPA)

USP, Ph.Eur, BP, IP, JP, CDMF

50-81-7

L(+)Ascorbic acid

USP, Ph.Eur, IP

79-33-4

L-(+)-Lactic acid

USP-NF, BP, IP, JP

1309-48-4

Magnesium oxide light

USP, Ph.Eur, IP

110-16-7

Maleic acid

USP-NF, Ph.Eur, BP, IP

6915-15-7

DL-Malic acid

USP-NF, Ph.Eur, IP

108-39-4

meta-Cresol

USP, Ph.Eur, BP, CDMF

96-27-5

Monothioglycerol

USP-NF, IP, CDMF

108-95-2

Phenol

USP, Ph.Eur, IP

122-99-6

Phenoxyethanol

BP, USP-NF, Ph.Eur, IP

60-12-8

Phenyl ethyl alcohol

USP, IP

8003-05-2

Phenylmercuric nitrate

USP-NF, Ph.Eur, IP

12

Binders

•

•

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Chelating agent

Coating agents

Lubricants

pH adjustment

Plasticizer

Preservatives

Antioxidants

Surfactants/ Stabilizers

Humectants

Emulsifying agents

Ointment base

• • • • • •

• • • •

•

•

•

•

•

•

• • •

• • • • •

•

• • •

• •

•

• •

• •

•

•

• • • • • •

• • •

•

• • • •

13

Excipients for Solid/Semi-solid Dosage Forms

CASR No.

Product Name

Pharmacopoeia / DMF

7664-38-2

Phosphoric acid

USP-NF, Ph.Eur, IP

25322-68-3

Polyethylene glycol 400

USP-NF, Ph.Eur

6100-05-6

Potassium citrate

USP, Ph.Eur, IP

7778-77-0

Potassium di-hydrogen ortho-phosphate

USP-NF, Ph.Eur

57-55-6

Propylene glycol

USP, Ph.Eur, BP, IP

69-72-7

Salicylic acid

USP, Ph.Eur, IP

127-09-3

Sodium acetate anhydrous

USP

6131-90-4

Sodium acetate trihydrate

USP, Ph.Eur, BP, IP

532-32-1

Sodium benzoate

USP-NF, Ph.Eur, BP, IP

144-55-8

Sodium bicarbonate

USP, Ph.Eur, BP, IP

7631-90-5

Sodium bisulfite

JP

497-19-8

Sodium carbonate anhydrous

USP-NF, BP, IP

7647-14-5

Sodium chloride

USP, Ph.Eur, BP, IP

7558-80-7

Sodium di-hydrogen o-phosphate anhydrous

USP, BP, IP

13472-35-0

Sodium di-hydrogen o-phosphate dihydrate

USP, Ph.Eur, BP, IP

7681-57-4

Sodium metabisulphite

USP-NF, Ph.Eur, IP

110-44-1

Sorbic acid

USP-NF, Ph.Eur, BP, IP

110-15-6

Succinic acid

USP-NF

87-69-4

Tartaric acid

USP-NF, Ph.Eur, IP, CDMF

54-64-8

Thimerosal

USP, Ph.Eur, BP, IP

102-76-1

Triacetin

USP, Ph.Eur

77-93-0

Triethyl citrate

USP-NF, Ph.Eur, IP

6132-04-3

tri-Sodium citrate dihydrate

USP, Ph.Eur, IP

102-71-6

Trolamine (Triethanolamine)

USP-NF, Ph.Eur

57-13-6

Urea

USP, Ph.Eur, BP, IP

1314-13-2

Zinc oxide

USP, Ph.Eur, IP

14

Diluents/ Fillers

•

Binders

•

•

•

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Bulking agents

Coating agents

Lubricants

pH adjustment

Plasticizer

Preservatives

Antioxidants

Surfactants/ Stabilizers

Humectants

Emulsifying agents

Ointment base

• •

•

•

•

•

•

• • •

•

• •

•

•

•

•

• •

• •

•

•

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• • • •

•

•

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15

Other Excipients CASR No.

Product Name

Pharmacopoeia / DMF

64-19-7

Acetic acid glacial (for haemodialysis)

USP, Ph.Eur, BP, IP, JP

10035-04-8

Calcium chloride dihydrate

USP, Ph.Eur, IP

67-66-3

Chloroform

IP

110-40-7

Diethyl sebacate

USP-NF

6132-05-4

di-Sodium hydrogen citrate

Excipient grade

7558-79-4

di-Sodium hydrogen o-phosphate anhydrous

USP, Ph.Eur, BP

10028-24-7

di-Sodium hydrogen o-phosphate dihydrate

USP, Ph.Eur, BP

7782-85-6

di-Sodium hydrogen o-phosphate heptahydrate

USP

118830-14-1

di-Sodium hydrogen o-phosphate monohydrate

USP

7791-18-6

Magnesium chloride hexahydrate

USP, Ph.Eur, BP, IP

7785-87-7

Manganese sulphate

USP, Ph.Eur, BP

119-36-8

Methyl salicylate

BP, IP

123-86-4

n-Butyl acetate

Excipient grade

110-54-3

n-Hexane

Excipient grade

6153-56-6

Oxalic acid

Excipient grade

139-05-9

Sodium cyclamate

Ph.Eur

10049-21-5

Sodium di-hydrogen o-phosphate monohydrate

USP, BP, IP

26970-82-1

Sodium selenite pentahydrate

Ph.Eur, BP

10102-17-7

Sodium thiosulphate pentahydrate

USP, Ph.Eur

109-99-9

Tetrahydrofuran

Excipient grade

108-88-3

Toluene

Excipient grade

16

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Appendix Product Name

Pharmacopoeia / DMF

Page Number

Acetic acid glacial (for haemodialysis)

USP, Ph.Eur, BP, IP, JP

16

Acetone

USP-NF, Ph.Eur, BP, CDMF

6, 8, 9, 10, 12

Acetonitrile

USDMF, CDMF

6, 8, 9

Benzalkonium chloride 50% Solution

USP-NF, Ph.Eur, IP, BP

6,12

Benzene sulphonic acid

USDMF, CDMF

6, 8, 9

Benzethonium chloride

USP, Ph.Eur

12

Benzoic acid

USP, Ph.Eur, IP

6,12

Benzyl alcohol

USP-NF, Ph.Eur, BP, IP

6, 8, 10, 12

Benzyl benzoate

USP, Ph.Eur, BP, IP, CDMF

6, 8, 10, 12

Butylated hydroxyanisole

USP-NF, Ph.Eur, CDMF

8, 12

Butylated hydroxytoluene

USP-NF, Ph.Eur, IP, CDMF

6, 8, 12

Calcium acetate

USP

12

Calcium carbonate

USP, Ph.Eur, BP, IP

12, 13

Calcium chloride dihydrate

USP, Ph.Eur, IP

16

Calcium saccharate

USP, CDMF

6, 8

Chloroform

IP

16

Citric acid anhydrous

USP, Ph.Eur, IP

6,12

Citric acid monohydrate

USP, Ph.Eur, BP, IP

12

Creatinine

USP-NF, CDMF

6, 8, 12

Cyclohexane

USDMF

8

Dibutyl phthalate

USP-NF, Ph.Eur, BP

10, 12

Diethanolamine

USP-NF, IP

6, 12

Diethyl phthalate

USP, Ph.Eur, IP

10, 12

Diethyl sebacate

USP-NF

16

Diethylene triamine pentaacetic acid (Pentetic acid)

USP

9

Diisopropanolamine

USP

6

Dimethyl formamide

USP

11

Dimethyl isosorbide

Excipient grade

11, 12

Dimethyl sulphoxide

USP, Ph.Eur

6, 10, 11

Dioctyl sodium sulphosuccinate (DOSS) (Monoxal OT)

USP, Ph.Eur

11, 12

di-Sodium hydrogen citrate

Excipient grade

16

di-Sodium hydrogen o-phosphate anhydrous

USP, Ph.Eur, BP

6, 16

di-Sodium hydrogen o-phosphate dihydrate

USP, Ph.Eur, BP

16

di-Sodium hydrogen o-phosphate dodecahydrate

IP, BP, USP, Ph.Eur

6

di-Sodium hydrogen o-phosphate heptahydrate

USP

6, 16

di-Sodium hydrogen o-phosphate monohydrate

USP

16

di-Sodium succinate hexahydrate

USDMF, USP, CDMF

6, 8, 9

EDTA calcium disodium

USP

12

EDTA di-sodium salt dihydrate

USP, Ph.Eur, IP

6, 12

Ethyl acetate

USP-NF, Ph.Eur

10

Formaldehyde

USP, Ph.Eur, BP

12

Fumaric acid

USP-NF, IP, CDMF

8, 9, 12

Glycerin

USP, Ph.Eur, BP, IP, JP

8, 10, 12

Glycerol 85%

Ph.Eur

10, 11, 12

Glycine

IP, Excipient grade

12

Hexylene glycol

USP-NF

10, 11, 12

Isopropyl alcohol (IPA)

USP, Ph.Eur, BP, IP, JP, CDMF

8, 10, 12

L(+)Ascorbic acid

USP, Ph.Eur, IP

6, 12

L-(+)-Lactic acid

USP-NF, BP, IP, JP

6, 12

Lauryl lactate

USDMF

8, 11

Levulinic acid

USDMF, CDMF

8, 9, 11

Liquefied Phenol

USP

6

Magnesium chloride hexahydrate

USP, Ph.Eur, BP, IP

6, 16

Magnesium oxide light

USP, Ph.Eur, IP

12

Maleic acid

USP-NF, Ph.Eur, BP, IP

12

DL-Malic acid

USP-NF, Ph.Eur, IP

12

17

Appendix Product Name

Pharmacopoeia / DMF

Page Number

Manganese sulphate

USP, Ph.Eur, BP

16

meta-Cresol

USP, Ph.Eur, BP, CDMF

6, 12

Methane sulphonic acid

USDMF, CDMF

6, 8, 9

Methyl alcohol (Methanol)

USP-NF, Ph.Eur, BP, CDMF

8, 10, 11

Methyl salicylate

BP, IP

16

Methylene chloride (Dichloromethane)

USP-NF, Ph.Eur, BP, CDMF

8, 10

Monosodium glycine carbonate

USDMF

8, 9

Monothioglycerol

USP-NF, IP, CDMF

6, 12

n-Butyl acetate

Excipient grade

16

n-Butyl alcohol

USP-NF

10

N,N-Dimethyl acetamide

USDMF, Ph.Eur, CDMF

6, 8, 9

n-Heptane

USDMF

8, 9

n-Hexane

Excipient grade

16

N-Methyl-2-pyrrolidone

USP-NF, Ph.Eur

6,10

Oxalic acid

Excipient grade

16

Phenol

USP, Ph.Eur, IP

6, 12

Phenoxyethanol

BP, USP-NF, Ph.Eur, IP

12

Phenyl ethyl alcohol

USP, IP

12

Phenylmercuric nitrate

USP-NF, Ph.Eur, IP

12

Phosphoric acid

USP-NF, Ph.Eur, IP

14

Polyethylene glycol 400

USP-NF, Ph.Eur

6, 10, 14

Potassium chloride

USP, Ph.Eur, BP, IP

6

Potassium citrate

USP, Ph.Eur, IP

14

Potassium di-hydrogen ortho-phosphate

USP-NF, Ph.Eur

6, 14

Propylene carbonate

USP-NF

10

Propylene glycol

USP, Ph.Eur, BP, IP

6, 8, 10, 11, 14

Salicylic acid

USP, Ph.Eur, IP

14

Sodium acetate anhydrous

USP

14

Sodium acetate trihydrate

USP, Ph.Eur, BP, IP

6, 14

Sodium benzoate

USP-NF, Ph.Eur, BP, IP

6, 14

Sodium bicarbonate

USP, Ph.Eur, BP, IP

14

Sodium bisulfite

JP

6, 14

Sodium caprate

Excipient grade

9

Sodium carbonate anhydrous

USP-NF, BP, IP

14

Sodium chloride

USP, Ph.Eur, BP, IP

6, 14

Sodium cyclamate

Ph.Eur

16

Sodium di-hydrogen o-phosphate anhydrous

USP, BP, IP

6, 14

Sodium di-hydrogen o-phosphate dihydrate

USP, Ph.Eur, BP, IP

14

Sodium di-hydrogen o-phosphate monohydrate

USP, BP, IP

16

Sodium metabisulphite

USP-NF, Ph.Eur, IP

6, 8, 14

Sodium selenite pentahydrate

Ph.Eur, BP

16

Sodium sulfite anhydrous

USP-NF, Ph.Eur

6

Sodium tartrate

USP-NF

6

Sodium thiosulphate pentahydrate

USP, Ph.Eur

16

Sorbic acid

USP-NF, Ph.Eur, BP, IP

14

Succinic acid

USP-NF

6, 8, 14

Tartaric acid

USP-NF, Ph.Eur, IP, CDMF

8, 14

tert-Butanol

USDMF, CDMF

6, 8

Tetraethyl orthosilicate

USDMF

8

Tetrahydrofuran

Excipient grade

16

Thimerosal

USP, Ph.Eur, BP, IP

14

Toluene

Excipient grade

16

Triacetin

USP, Ph.Eur

10, 14

Triethyl citrate

USP-NF, Ph.Eur, IP

8, 10, 14

tri-Sodium citrate dihydrate

USP, Ph.Eur, IP

6, 14

Trolamine (Triethanolamine)

USP-NF, Ph.Eur

6, 14

Urea

USP, Ph.Eur, BP, IP

11, 14

Zinc oxide

USP, Ph.Eur, IP

14

18

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Specifications and regulatory standards for the pharmaceutical industry are ever evolving. A need for more efficient and innovative drugs is always increasing which makes today an ideal time to reformulate. With a comprehensive range of excipients, consistent quality and a resilient supply chain Finar helps you turn today’s formulations into tomorrow’s opportunity.

19

Finar Limited Corporate Office & Works

Ver. 0920

184-185-186/P, Village: Chacharwadi -Vasna, Bavla 8 Km Milestone, Sarkhej Bavla Highway, Ta .: Sanand, Dist.: Ahmedabad-382110, India.

Phone: +91-2717-616717

Sales Office 1218, 12th Floor, Hub Town Solaris, N S Phadke Marg, Near Andheri Bridge, Andheri (E), Mumbai-400 069, India.

Phone: +91-22-26848958 / 26836324 excipients@finarchemicals.com

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