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Annexure I: Legal Undertaking for Three Conditions

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Annexure I: Legal Undertaking for Three Conditions A-1 A-2 A-3 A-4 A-5 A-6 A-7 A-8 A-9 A-10 A-11 A-12 A-13 A-14 A-15 A-16 A-17 A-18 A-19 A-20 A-21 A-22 A-23 A-24 A-25 A-26 NAME OF PRODUCT : TESTOSTERONE MAXIMUM QUANTITY TO BE : 2.2605 MT/Month PRODUCED Raw Materials Require: Raw Materials Quantity in MT/Month (MAXIMUM) 3-Enol ether OR 4-AD 3- 2.9387 ethoxyandrosta-3,5-dien-17-one Ethanol 8.8160 Triethylamine 0.0723 Sodium Borohydride 0.6782 Hydrochloric acid 2.2605 Water 6.7815 Ethyl Acetate 6.7815 MDC 1.1303 Charcoal + Hyflow 0.0452 Brief Process: 3-Enol etherOR 4-AD 3-ethoxyandrosta-3,5-dien-17-one will be converted into 3-Enol hydroxyOR 4-AD 3-ethoxyandrosta-3,5-dien-17-ol in presence of sodium borohydride and triethylamine, further this compound converts into crude testosterone by treating with 10% hydrochloric acid. This crude material purified by charcoal treatment with organic solvents. CHEMICAL REACTIONS: A-27 1. TESTOSTERONE 4- AD -1.3 KG ETHANOL – 3.9 KG WATER 3.0 KG SODIUM BOROHYDRIDE- 0.3KG TRIETHYL AMINE - 0.032 KG HCL (10%) 1.0 KG 9.532 KG CRUDE TESTOSTERON eeTESTOSTERON FILTERATION ML-8.32 kg STRIPPER 1.2 KG 4.5kg Solvent ETHYL ACETATE – 3.0kg (Ethanol)-3.8kg KG MDC – 0.5 KG 4.72 KG CHARCOAL + HYFLOW – 0.02KG ETP / MEE FILTERATION Charcoal +Hyflow-0.02kg Solvent-3.44kg Residue-0.26kg Product – 1.0 kg A-28 NAME OF PRODUCT : TESTOSTERONE PROPIONATE MAXIMUM QUANTITY TO BE : 2.2605 MT/Month PRODUCED Raw Materials Require: Raw Materials Quantity in MT/Month (MAXIMUM) Testosterone 2.2605 MDC 22.605 Pyridine 2.2668 Propionyl chloride 0.9042 Methanol 2.2605 Brief Process: Testosterone propionate reacts with propionyl chloride and yields testosterone propionate in presence of organic solvent MDC and methylene chloride and pyridine which purified by chacoalization process in organic solvent methanol. CHEMICAL REACTIONS: A-29 TESTOSTERONE PROPIONATE TESTOSTERONE - 1.0 KG METHANOL - 1.0 KG PYRIDINE- 1.0 KG PROPIONYL CHLORIDE -0.4 KG MDC -10.0 KG 13.4 KG CRUDE TESTOSTERON ETESTOSTERON FILTERATION ML-12.40kg STRIPPER Product – 1.0 kg Solvent – 11.76 Residue-0.64 kg kg A-30 NAME OF PRODUCT : TESTOSTERONE UNDECANOATE MAXIMUM QUANTITY TO BE : 2.2605 MT/Month PRODUCED Raw Materials Require: Raw Materials Quantity in MT/Month (MAXIMUM) Testosterone 2.2605 MDC 22.605 Pyridine 2.2605 Decanoyl chloride 0.9042 Methanol 2.2605 Brief Process: Testosterone propionate reacts with Decanoyl chloride and yields testosterone undecanoate in presence of organic solvent MDC and methylene chloride and pyridine which purified by chacoalization process in organic solvent methanol. CHEMICAL REACTIONS: A-31 TESTOSTERONE UNDECANOTE TESTOSTERONE - 1.0 KG METHANOL - 1.0 KG PYRIDINE- 1.0 KG DECANOYL CHLORIDE -0.4 KG MDC -10.0 KG 13.4 KG CRUDE TESTOSTERON ETESTOSTERON FILTERATION ML- STRIPPER 12.40kg Product – 1.0 kg Solvent -11.76 Salt - 0.64 kg kg A-32 NAME OF PRODUCT : TESTOSTERONE CYPIONATE MAXIMUM QUANTITY TO BE : 2.2605 MT/Month PRODUCED Raw Materials Require: Raw Materials Quantity in MT/Month (MAXIMUM) Testosterone 2.2605 MDC 31.647 Pyridine 2.2605 Cyclopropyl propionate chloride 2.2605 Methanol 2.2605 Brief Process: Testosterone reacts with cyclopropynyl propionate chloride and yields testosterone cypionate in presence of organic solvent MDC and methylene chloride and pyridine which purified by crystalization process in organic solvent methanol. CHEMICAL REACTIONS: A-33 TESTOSTERONE CYPIONATE TESTOSTERONE -1.0 KG MDC -7.0 KG PYRIDINE - 1.0 KG METHANOL-1.0 KG CYCLOPRONYL PROPINATE CHLORIDE -1.0 KG 11.0 KG CRUDE TESTOSTERON TESTOSTERON FILTERATION ML-10.0kg STRIPPER Product – 1.0 kg Solvent -8.82 Salt -1.180 kg kg A-34 NAME OF PRODUCT : NANDRALONE DECAONATE MAXIMUM QUANTITY TO BE : 2.2605 MT/Month PRODUCED Raw Materials Require: Raw Materials Quantity in MT/Month (MAXIMUM) Nandrolone 2.2605 MDC 9.0420 Pyridine 2.2605 Decanoylchloride 2.2605 Methanol 6.7815 Water 13.5630 Brief Process: Nandralone reacts with Decanoyl chloride and yields NandraloneDecanoate in presence of organic solvent toluene and methylene chloride and pyridine which purified by chacoalization process in organic solvent methanol. CHEMICAL REACTIONS: A-35 NANDRALONE DECAONATE NONDRALONE - 1.0 KG MDC - 4.0 KG PYRIDINE - 1.0 KG METHANOL - 3.0 KG DECANOYL WATER - 6.0 KG CHLORIDE - 1.0 KG 16.0 KG CRUDE TESTOSTERONE TESTOSTERON FILTERATION ML-15.0 kg STRIPPER Product – 1.0 kg Solvent 7.83 kg ML -6.0 kg Residue-1.17 A-36 NAME OF PRODUCT : NANDRALONE PHENYLPROPIONATE MAXIMUM QUANTITY TO BE : 2.2605 MT/Month PRODUCED Raw Materials Require: Raw Materials Quantity in MT/Month (MAXIMUM) Nandrolone 2.2605 MDC 9.0420 Pyridine 2.2605 Phenylpropionylchloride 2.2605 Methanol 5.6513 Water 13.6530 Brief Process: Nandralone reacts with Phenylpropionyl chloride and yields Nandralonephenylpropionate in presence of organic solvent toluene and methylene chloride and pyridine which purified by chacoalization process in organic solvent methanol. CHEMICAL REACTIONS: A-37 NANDRAOLONE PHENYL PROPIONATE NONDRALONE - 1.0 KG MDC - 4.0 KG PYRIDINE - 1.0 KG METHANOL - 2.5 KG PHEYNYL PROPIONYL WATER - 6.0 KG CHLORIDE - 1.0 KG 15.5 KG CRUDE TESTOSTERON TESTOSTERON FILTERATION ML-14.50 kg STRIPPER Product – 1.0 kg Solvent -7.38 Effluent-6.0 k g kg Residues-1.12 kg A-38 NAME OF PRODUCT : TRENBOLONE ACETATE QUANTITY TO BE PRODUCED : 0.05 MT/Month MAXIMUM QUANTITY TO BE : 2.2605 MT/Month PRODUCED Raw Materials Require: Raw Materials Quantity in MT/Month (MAXIMUM) Trenbolone 2.2605 Acetic anhydride 4.9731 Pyridine 4.9731 Sodium Chloride Hydrochloric acid 2.2605 Potable water 22.6050 25% Ammonia 0.2261 Brief Process: Trenbolone reacts with acetic anhydride and yields tranbolone acetate, which precipitated by sodium chloride and hydrochloric acid solution and finally purified in organic solvents by charcoalization. CHEMICAL REACTIONS: A-39 TRENBOLONE ACETATE AMMONIA - 0.1 KG TRAMBOLONE -1.0 KG PYRIDINE –2.2 KG ACETIC ANHYDRIDE - 2.2 KG HCl - 1.0 KG WATER -10.0 KG 16.5 KG CRUDE TRAMBOLONETESTOSTE RTESTOSTERONFILTERATION Mother Liquor-15.5 kg STRIPPER Product – 1.0kg Solvent – 4.32 kg Effluent- 11.18 kg A-40 NAME OF PRODUCT : TRENBOLONE ENANTHATE MAXIMUM QUANTITY TO BE : 2.2605 MT/Month PRODUCED Raw Materials Require: Raw Materials Quantity in MT/Month (MAXIMUM) Trenbolone 2.2605 Heptanoic Anhydride / 4.9731 Enthanate Anhydride Pyridine 5.4252 Sodium Chloride Hydrochloric acid 2.2605 Potable water① 22.6050 25% Ammonia 0.2261 Brief Process: Trenbolone reacts with Heptanoic Anhydride and yields Enanthate, which precipitated by sodium chloride and hydrochloric acid solution and finally purified in organic solvents by charcoalization. CHEMICAL REACTIONS: A-41 TRENBOLONE ENTHANATE AMMONIA - 0.1 KG TRAMBOLONE -1.0 KG PYRIDINE –2.4 KG ENANTHIC ANHYDRIDE - 2.2 KG HCl - 1.0 KG WATER -10.0 KG 16.7 KG CRUDE TRAMBOLONETESTOSTE RTESTOSTERONFILTERATION Effluent-15.7 kg Product – 1.0 kg A-42 NAME OF PRODUCT : METHANDIENONE MAXIMUM QUANTITY TO BE : 2.2605 MT/Month PRODUCED Raw Materials Require: Raw Materials Quantity in MT/Month (MAXIMUM) Methyl testosteronum 2.939 Toluene 20.345 2,3dicyno-5,6- 2.261 dichlorobenzoquinone (DDQ) p-Nitrophenol 2.261 Sodium hydroxide 4.521 Potable water 56.513 Sodium sulphite 22.605 Methanol 1.808 Activated charcoal 0.226 Isopropyl Ether 6.782 n-hexane 4.521 Ethyl Acetate 15.824 Brief Process: Methyltestosteronum compound converted into crude methandienone in presence of p- nitrophenol and 2,30dicyno-5,6-dichlorobenzoquinone (DDQ) which is isolated by concentrating organic layer under vacuum. This crude material is purified in solvent by using activated alumina and charcoal CHEMICAL REACTIONS: A-43 METHANDIENONE METHYL TESTOSTERONEM -1.3KG TOLUENE-9.0 KG WATER - 15KG SODIUM HYDROXIDE – 2.0 KG 2,3DICYNO-5,6 DICHLORO PARANITRO PHENOL - 1.0 KG BENOQUINONE - 1.0 KG (DDQ) 29.3 KG CRUDE FILTERATION ML-39.3 kg STRIPPER 1.0 KG MEE Solvent – 19.11kg 20.19 kg (Toluene – 8.3kg IPE- 3.0KG HEXANE (2.0 KG) IPE-2.4kg 12.0 KG Hexane-1.66kg ETHYL ACETATE -7.0KG Ethyl Acetate- 6.75kg) Residue – 0.30kg PURIFICATION 1.0 KG Sodium Sulphite – 10 Charcoal – 0.1 21.9 KG Water – 5 .0 kg Methanol – 0.8 Water – 5.0kg DISTILLATION Charcoal-0.1 Methanol-0.8 Effluent-20.0 Product – 1.0kg A-44 NAME OF PRODUCT : OXYMETHOLONE MAXIMUM QUANTITY TO BE : 2.2605 MT/Month PRODUCED Raw Materials Require: Raw Materials Quantity in MT/Month (MAXIMUM) Mestanolone 2.486 N,N-Dimethylformamide 12.4328 Ethylenediaminetetraacetic acid 0.0025 disodium salt Sodium methanolate 0.6216 Ethyl formate 0.9494 Water① 37.2983 Dichloromethane 14.919 Sodium carbonate 0.2034 98%Sulfuric acid 2.4866 Sodium Bicarbonate 0.2034 Methanol 13.563 Charcoal 0.2487 Brief Process: Mestanolone is reacted with ethylenediamainetetraacetic acid disodium in presence of dimethyl formamide, sodium methoxide and ethyl formate and yields crude oxymetholone which is purified in organic solvent by charcoalization in pure form. CHEMICAL REACTIONS: A-45 OXYMETHALONE DI CHLORO METHANE-6.6 KG MESTONOLONE -1.1KG N,N DIMETHYL FORMAMIDE-.5.5 KG WATER-16.5 KG SODIUM METHOXIDE-0.275 KG EDTA SODIUM SALT-0.0011KG MTHYL FORMATE -0.42 KG SODIUM CARBONATE -0.09 KG 30.4861 KG SULPHURIC ACID -1.1 KG EXTRACTION ML- MEE SODIUM BICARBONATE 21.4961 KG MEE 0.09 KG 15.18 KG WATER-5.0 KG ORGANIC LAYER EXTRACTION SOLVENT- ML -13.0911 8.405kg MDC-10.6 kg MEE WATER +PRODUCT (4.58 KG) FILTERATION ML-3.08 KG MEE METHANOL-6.0 KG CRUDE CHARCOAL-0.11 KG (7.61 KG) FILTERATION 6.61 KG Product – 1.0kg STRIPPER METHANOL RESIDUE (6.4 KG) (0.21KG) A-46 -NAME OF PRODUCT : STANOZOLOL MAXIMUM QUANTITY TO BE 2.2605 MT/Month PRODUCED Raw Materials Require: Raw Materials Quantity in MT/Month (MAXIMUM) Oxymetholone 2.4866 Dichloromethane① 17.049 diatomite 0.1243 Dichloromethane② 3.3026 Hydrazine hydrate 0.5583 Brief Process: Oxymetholone is reacted with diatomite and then with 80%hydrazine hydrate in presence of methylene chloride and yields stanozolol.
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