1. The certificate of analysis is for a batch of Amoxicillin Oral Suspension produced by Associated Biotech. It provides results of quality testing performed on samples from the batch.
2. All quality tests were passed, including those for identification, fill weight, dosage uniformity, pH, assay/potency, and microbiological purity. The product meets specifications for an oral suspension containing 125mg/5mL of amoxicillin.
3. The batch is approved for release and should be stored below 25°C, protected from light and moisture, with an expiration date of January 2024.
1. The certificate of analysis is for a batch of Amoxicillin Oral Suspension produced by Associated Biotech. It provides results of quality testing performed on samples from the batch.
2. All quality tests were passed, including those for identification, fill weight, dosage uniformity, pH, assay/potency, and microbiological purity. The product meets specifications for an oral suspension containing 125mg/5mL of amoxicillin.
3. The batch is approved for release and should be stored below 25°C, protected from light and moisture, with an expiration date of January 2024.
1. The certificate of analysis is for a batch of Amoxicillin Oral Suspension produced by Associated Biotech. It provides results of quality testing performed on samples from the batch.
2. All quality tests were passed, including those for identification, fill weight, dosage uniformity, pH, assay/potency, and microbiological purity. The product meets specifications for an oral suspension containing 125mg/5mL of amoxicillin.
3. The batch is approved for release and should be stored below 25°C, protected from light and moisture, with an expiration date of January 2024.
1. The certificate of analysis is for a batch of Amoxicillin Oral Suspension produced by Associated Biotech. It provides results of quality testing performed on samples from the batch.
2. All quality tests were passed, including those for identification, fill weight, dosage uniformity, pH, assay/potency, and microbiological purity. The product meets specifications for an oral suspension containing 125mg/5mL of amoxicillin.
3. The batch is approved for release and should be stored below 25°C, protected from light and moisture, with an expiration date of January 2024.
ASSOCIATED BIOTECH Quality Control Department Certificate of Analvsis Product Name : Amoxicilina Suspension Oral USP 250 mg/5 ml GenerieName : Amoxicillin for Oral Suspension USP Batch Number : DANI22|39 A.R. No. : FPB0123037 Batch Size : 12000 Bottles Mfe. Date : ll/2022 Qty. Sampled !' 25 Bottles Exp. Date : 1012024 Receipt Date : 05.01.2023 Released Date : 74:01.2023
Sr. No. Test Specification Result
1 Description White to off white powder filled in 60 White to off white powder ml HDPE bottle, give. off pleasant filled in 60 ml HDPE bottle flavoured pink suspension after give off pleasant flavoured reconstitution. pink suspension after reconstitution. 2. Identification (By HPLC) The retention time of the major Amoxicillin trihvdrate peak of the sample solution correspond to that of the standard v solution, as obtained in the assay. Positive Average fill weight/bottle 18.0 sn / bottle +.5.Uoh 18.0043 gm/bottle 4. Uniformity of fill weight +.9.jvo average fill weight Complies 5. Deliverable volume Meets the requirement Complies 6. Uniformity of doges units LI t5 9.20 n pH 5.0 to 7.5 6.12
8. Weight per ml l.l gm/ml +5.0% 1.0953 en/ml
9, Assay (By HPLC)
Each 5 ml reconstituted suspension contains: Amoxicillin Trihydrate USP Eq. to Amoxicillin 250 mg 225.0mgto 300.0 mg 272.72m9 After reconstituted ( Keep the reconstituted suspension in refrigerator for 7 days) 10. pH 5.0 to 7.5 6.29
ll Assay (ByHPLC) v Each 5 ml reconstituted suspension contains: Amoxicillin Trihydrate USP Eq. to Amoxicilliri 250mg NLT 225.0 me 268.27 mg
12. Microbiological purity Total aerobic microbial count
(TAMC)NMT 103cfrr/gm. 65 ctu/gm Total Combined Yeasts and Molds count (TYMC) NMT 102 cflr/gm. Nit E. coli should be absent in I em preparation. Absent
Remarks: The above sample conffies/doesaffrcomply with prescibed standard of qualiry per USP spec specification.
in cool & Iace below 25"C and from
Analysed Bv Checked By Annroved Bv Signature q-.- /ila^ ,4i '-----=' Date t,r (o I 1>-2 tQ l" tl ll - r r, lblbz Vill l(ishonnrrrq (Irrrrr Moiro Dnod Teh Nolo rh-11tlfi f '1 ASSOCIATED BIOTECH Quality Control Department Certificate of Analvsis Product Name:2 MOX Generic Name : Amoxicillin Oral Suspension IP Batch Number : AMD2001 A.R. No. : FPB0922050
BatchSize r ! 3,000 Bottles Mfg. Date : AUG.2022
Qty. Sampled : 15 Bottles Exp. Date : JAN.2024
Receipt Date : 09.09.2022 Released Date z 21.09.2022
Sr. No. Test Specification Result
I Description White to off white powder, give White to off white powder, give pleasantly flavoured off white pleasantly flavoured off white suspension after reconstitution. suspension after reconstitution.
2. Identification (By HPLC) In the assay, the principal peak
Amoxycillin trihydrate in the chromatogram obtained €) with the test solution corresponds to the peak in the chromatogram obtained with the reference solution Positive a Average fill weight 16 gm /bottle + 5.0% 16.0208 gm/bottle
4. Uniformity of fill weight +9.0% of average fill weight Complies
5. pH 5.0 to 7.5 6.2s 6. Weight per ml 1.1 er/ml +.5.0% 1.0818 gm/ml 7. Assay (By HPLC) Each 5 ml of the reconstituted suspension contains: Amoxycillin trihydrate IP eq. to Amoxycillin 125 mg 112.5 mgto 150.0 mg 128.15 mg After reconstituted (Keep the reconstituted suspension in refrigerator as per specified days) v 8. 9. pH Assay (By HPLC) 5.0 to 7.5 6.48
Each 5 ml of the rsconstituted
suspension contains: Amoxycillintrihydrate IP eq. to Amoxycillih 125 mg Not less than 100 .0 mg 127.27 mg
