_HALEWOOD LABORATORIES PVT LTD Plot No. 319, Phase ~ Il, G.LD.C. Area, Vatva, Ahmedabad - 382445 QC DEPARTMENT FINISH PRODUCT CERTIFICATE OF ANALYSIS Product Name Oral Rehydration Salt IP 20.5 GM@MBI GOVT), Generic Name ‘Oral rehydration salts IP 20.5 gm Batch No. NH23001 ARNO. HILOFI30096 Date of Mfg. FEB23 Batch Size. 200000 Sachets Date of Exp. JAN-26 Qty Sampled. | 615.000 Gm Date of Receipt. 05-02-2023 Date of Release | 07-02-2033 ‘Analysis Date : 07-08-2023 Specification No_| SPCAP/ORS-20.5/01-02 STP No. STPAPIORS-20.5/01-02 Sr.No Test Result Specification: 1.0 | Description White fo creamy white, amorphous | White to creamy white, amorphous or or crystalline powder, crystalline powder. 2.0 _| Tdentification Identification A when heated, melting and ‘when heated, melting and charring charring occurs and an odour of | occurs and an odour of burnt sugar is bumt sugar is Produce. Produce. Wentification B Gupric red precipitate is Cupric red precipitate should be produced on boiling produced on boiling | . Tdentification C Gives reaction A of sodium salts | Gives reaction A of sodium salts reaction A of potassium salts, . | reaction A of potassium salts, reaction reaction A of chloride. A of chloride. Tdentification D ‘A quality containing about 50.0 | A quality containing about 50.0 mg of | mg of citric acid give the citric acid should be give the reaction reaction of citrates of citrates 3.0_| Average weight 20.612 sim NET 205 em 40 | Uniformity weight Maxi + 0.19 % Min:-0.24% Average weight + 9% | 5.0 | Assay: Each 20.5 gm Sachet contain Dextrose anhydrous 13.59 am , 100.67 % Limit: 90% to 110% 13.5gm i “otal sodium 1,7029 em T182 gm, 100.90 % Limit: 90% to 110% Total potassium 0.7862 em 07919 gm, 100.73 % Limit: 90% 0 110% Total chloride 2.2905 gm 23011 gm , 100.46% Limit; 90% to 110% Total citrate 1.8646 gm 1.8413 gm , 98.75 % Limit: 90 % to 110 % es not comply as per IP Q.C.Manager: Date:“ -HALEWOOD LABORATORIES PVT LTD at Plot No, 319, Phase — If, G.LD.C. Area, Vatva, Ahmedabad — 382445 QC DEPARTMENT FINISH PRODUCT CERTIFICATE OF ANALYSIS Product Name "| Oral Rehydration Salt IP 20.5 GM(PMBI GOVT) Generic Name Oral rehydration salts IP 20.5 gm Batch No. NH23002 ARNO. HLOF230097 Date of Mig, FEB-23 Batch Size. 59,200 Sachets Date of Exp. _[JAN-36 QySampled. | 615.000Gm Date of Receipt. 06-02-2023 Date of Release | 07-02-2023 Analysis Date: 07-02-2023 Specification No _ | SPC/IP/ORS-20.5/01-02 : STP No. STPIP/ORS-20.5/01-02 ‘Sr.No Test Result Specification 1.0__| Description White to creamy white, amorphous | White to creamy white, amorphous or or crystalline powder. crystalline powder. Identification Identification A ‘when heated, melting and when heated, melting and charting charring occurs and an odour of | occurs and an odour of burnt sugar is burnt sugar is Produce. Produce. Identification B CCupric red precipitate is {| Cupric red precipitate should be produced on boiling produced on boiling Identification C Gives reaction A of sodium salts '| Gives reaction A of sodium salts reaction reaction A of potassium salts, _| A of potassium salts, reaction A of reaction A of chloride. chloride, Wentification D ‘A quality containing about 50.0 || A quality containing about 50.0 mg of mg of citric acid give the citric acid should be give the reaction of reaction of citrates citrates 3.0_| Average weight 20.623 gm NLT 20.5 gm 4.0 | Uniformity weight Max: + 0.29 % Min:-0.16% “Average weight + 9% 5.0_| Assay: Each 20.5 am Sachet contain Dextrose anhydrous 1344 gm 99.56% Limit: 90% t0 110% 13.5em Total sodium 1.7029 gm 1.7011 gm, 99.89 % Limit: 90 % to-110 % Total potassium 0.7862 em U.7758 gm, 98.68% Limit: 90% to 110% Total chloride 2.2905 gm 2.3219 gm, 101.37 % Limit: 90% to 110% Total citrate 1.8646 gm 1.8529 gm , 99.37% [ Limit: 99% to 110% Remark: The above sample(GomplieDoes not comply as per IP oat ceMameen(\ wW—3 carr Date: Page 1 of 1