AMOXYCILLIN- CLAVULANATE FOR INJECTION  is a penicillin-type of antibiotic that helps

your body fight infections caused by bacteria. It is used to treat infections of the lungs

(e.g., pneumonia), ear, nasal sinus, urinary tract, skin, and soft tissue. It will not work for

viral infections such as the common cold.

Amoxycillin- Clavulanate for Injection is generally administered by a healthcare professional

and should not be self-administered. Depending on the severity of your underlying illness,

your doctor will decide the precise dose and schedule as per which this injection is to be

given. It is strictly advised to be used as per the doctor’s prescription.

Common side effects of this medicine include nausea, vomiting, and diarrhea.

Additionally, you may notice some injection site reactions like pain, swelling, or redness.

Please consult your doctor if these do not get better or persist for a longer

duration of time. In cases of patients with severe liver or kidney disease, consult

your doctor before you start the treatment.

Before using it, you should tell your doctor if you are allergic to any antibiotics or

have any kidney or liver problems. Your doctor may change the dose or prescribe

a different medicine. This medicine is generally regarded as safe to use during pregnancy

and breastfeeding if used under a doctor’s supervision.


Generic Name: Amoxycillin- Clavulanate for Injection

Strength:600 MG

Lot size:70500 units

Average Filled Weight:666 mg/vial

Label Claim: Each vial contains:

Amoxycillin Sodium & Clavulanate Potassium USP

Equivalent  ___________ 600 mg

Shelf Life: 2 Years

Dosage Form: Dry powder for Injection  ( For IM / IV Use ).

OPERATING PARAMETERS:Room Temperature : 23 + 2°C  , Relative Humidity: 25 + 5 %.


S.No Ingredient Standard Quantity Compensation Factor  Required Quantity
01  Amoxycillin sodium & Clavulanate Potassium USP 42.30 KG 11.00% 46.953 KG*

* Exact Required Quantity depends upon Assay and Moisture / LOD content of Raw Materials.


Required Quantity of Amoxycillin sodium& Clavulanate Potassium

=   Lot Size in No. X 0.60 gm X 10  / Assay on an anhydrous basis X (100 – Moisture)


Item Specification
 Vials 10 ml Vial White Type I
Seal 20mm F/O -Black[CODE-C]
Plugs Rubber Plugs 20mm Bromo Butyl


The area is free from unwanted material as well as the material from the last batch/ product.

All equipment and containers used in processing in this batch are cleaned to the required standard.

The wash water analysis report is available in case of product change over.

The product is labeled at all stages with all details such as the name of the product, Lot no.,

and Mfg. date, Exp. date.

All the instructions of manufacturing procedure are strictly followed and any deviation is made

only after consultation of manager Q.A and recorded.

The temperature and relative humidity of the manufacturing area is 23 + 2°C &

20% – 30% respectively and these parameters are checked and recorded

every 1 hour by operation and 2 hours by QA during the process.

A sterile dress is worn during the manufacturing process.

All the critical parameters are to be recorded as per BMR.


All parts in contact with the product must be of inert material.

Wear proper dress and accessories while handling raw materials.

Keep the sample collected at each stage separately till the batch manufacturing is Completed.

Check autoclave load indicators (chemical) of sterile loads before using every individual

Check all prints out of equipment.


S.No. Equipment Previous product
1 SS Hopper
2 Linner vial machine
3 Vial filling and stoppering machine
4 Vial sealing machine
5 SS Treys
6 Sterilization and depyrogenation Tunnel
7 Autoclave
8 Electronic balance


Manufacturing chemist shall punch material requisition slip in ERP and take a

printout Signed and shall give it to store in charge .

Store In charge dispenses the approved raw material in the presence of the

production person and IPQA person.

IPQA person shall tally the weighed quantity with requisition slips and shall sign

on dispensing sheet and BMR.

The storekeeper shall fill the issued quantity and analytical control number on BMR

and sign it  & transfer the dispensing raw material to the filling section.

Issue the required quantity of primary packing material from the store.


Remove approved empty vials from the boxes in De-cartoning area and load

the vials on the conveyor of vial washing machine .

Wash the vials in automatic liner vial washing machine as per validation cycle and SOP .

Checking of washed vials done by production and IPQA In charge at frequent interval .

After washing vials are automatically transferred in sterilization and depyrogenation

tunnel for sterilization and depyrogenation . Check pressure of different zone of the tunnel,

and sterilization temperature and conveyor speed of tunnel at every hours .

After sterilization vials are automatically transferred in filling area .

If rubber stoppers are not Ready for use then wash and sterilized the rubber plug in

bung processor with HPW and transferred the washed and sterilized rubber plug to

the filling area.


Maintain the temperature and relative humidity of the filling area before doing

filling process and recorded at frequent interval .

Take the Blended raw materials under sterile condition .

Fill the blended sterile powder in the hopper  and starts filing operation .

Adjust the fill weight of the powder ( Range – 666 mg ± 2% )

After filling  rubber plugs are automatically bunged  on filled vial by automatic

plugging machine.

Seal the vials with the help of automatic vial sealing machine.

Check the weight variation , Temperature , RH % , Pressure differential and sealing

of vials after every hour .


Check the filled vials for the presence of any foreign partials.

Keep the good vials separate with a label containing the product name,

lot No., Mfg.Date, Exp.Date.

Keep the rejected vials in separate tray labels of the type of rejection.

Transfer the good vials to the Quarantine Section.

IPQA In-charge does the random sampling of products for final analysis by QC.


The packing area is free from unwanted material as well as material

from the last batch/product.

The line equipment and containers are properly identified.

Care is taken to avoid mix up during all stages of packing.


Take the dispense packing material that is labeled, carton, literature, inner carton

box and outer carton box etc.

Take the vials from quarantine area for labeling, paste the printed labels on the vials

with the help of labeling machine.

Check the initial coding of labels for batch No. Mfg.Date, Exp.Date and MRP.

Check the labeled vial and packing carton with packing insert.

Packing supervisor and IPQA In charge shall randomly inspect the quality of labeling

and coding every two hours.

Pack the final product in corrugated boxes.

After the QA approval transfer the finish product to store .


S.No Parameters Standards Frequency
1 Colour of reconstituted solution Clear Colourless solution At the time of reconstitution
2 Fill Weight Check 666 mg ±2% 2 Hours
3 Cleanliness of filled vial Should be clean 2 Hours
4 Seal Check 20mm F/O Black 2 Hours
5 Mould Defect All the Vials should pass 2 Hours
6 Overprinting  on Labels  and

other Packing material.

At the time of packing 2 Hours
7 pH 8.0 – 10.0 At the time of finished product   testing
8 Assay Between 90% to 110% of label claim At the time of finished product   testing
9 Water/LOD/Moisture NMT 3.5 %w/w At the time of finished product   testing


S.No Process Theoretical Permissible
1 Bulk 100 % 98 – 99.5%
2 Filling 99.0% 97 – 99.0%
3 After visual inspection and packing 97% 96 – 97%


S.No. Equipment Make Purpose
1. Weighing Balance Citizen Weight Adjustment
2. Vial Washing Machine Laxmi Pharma Washing of Vials
3. Sterilizing Tunnel Fabtec Sterilization & Depyrogenation of Washed Vials
4. Autoclave Metal Chem Sterilization of Dresses , filling item and accessories
5. Filling  and sealing Machine Fabtec Filling of powder into Vials
6. External Vial Washing machine N.K. Pharma Products External washing of vial
7. Visual Inspection Table Pragathi Visual inspection
8. Labeling Machine Ambica Vial Labeling


Raw material analyzed and released by Q.C for filling.

Filled Vials are drawn online for analysis by IPQA.

All the analytical tests are performed by QC Chemist from Quality Control.

The batch is released after 14 days.


10 labeled and duly packed Vials are collected online by IPQA In charge during

packing and sent to QC for storage in the control sample room.


Control samples are destroyed 3 months after the expiry of the batch as per the

standard operating procedure. Destruction records are to be maintained.

Filled rejected Vials are first inactivated by using suitable chemicals and then

destroyed by crushing as per the standard operating procedure. Printed packing material is

destroyed by shredding it into small pieces.


All the documents are Checked by the department head or concerned person

and duly signed by authorized Q.A. personnel.

Batch records are to be preserved for 5 years after manufacturing in the record room.


Packed finished goods are transferred to FGS  after proper entry in ERP.

Dispatched after finished good inspection by IPQA and release by QA HEAD.

Distribution records are maintained at finished goods stores.


Generic name: Amoxycillin  and Potassium Clavulanate for Injection

Party Name:

Claim: Each vial  contains:

Sterile  Amoxycillin Sodium to  Amoxycillin……………………………………… 500 mg

Sterile   Potassium Clavulanateeq. to  Clavulanic acid ……………………….. 100mg

Description of Product:

White to pale yellow/cream colored crystalline powder filled in glass vials and

sealed with rubber plug and flip-off aluminum seal.

S. No. Component Brief Description Qty./Super


Packaging Instructions
1. Glass Vial 10 ml 10 ml type- I Vial with 20 mm Neck, Neutral glass 240 No. Fill Sterile powder as per required weight aseptically.
2. Rubber plug 20 mm Bromo Butyl 240 No. Plug the vial using a sterile rubber plug aseptically.
3.  Flip-off seal

( Black )

20mm standard virgin flip-off aluminum seal with a black color plastic flip. 240 No. Seal the vial properly using flip-off aluminum seal.
4.  Label


Sticker Label for vial printed as per the approved color, text & design on GSM 80 ± 10%.

Size :  70 x 28 mm ± 1 mm

240 No. Paste one label on each vial duly coded with batch No. Exp. date & Mfg. Date.
5. Unit carton


Unit carton made up of 300 GSM ± 10% laminated art card, printed as per approved text, color and design.

Size :  34 x 34 x 62 mm ± 1 mm

240 No. Put 1 vial in each unit carton duly coded with all batch details.
6. Literature As per party artwork 240 No. Put 1 in each unit carton.
7. Shrink pack


Shrink pack made from 9-inch polythene roll 24 Nos.


Pack 10 unit cartons in each shrink pack.
8. Master Corrugated box


Corrugated box made up of 3 ply as per approved design, color, and text,

Size:  220x 180 x 138 mm ± 3mm

  04 Nos. Put 6 shrink packs in each master corrugated box.
9. Super Master corrugated box (Shipper Master ) Corrugated box made up of  5 ply as per approved design, color, and text,

Size – 370 x 237 x 290 mm  ± 3mm

01 No. Put 04 master Corrugated boxes in each super master corrugated box.
10.  BOPP tape

Brown plain

48 mm  ±1 mm wide self-adhesive BOPP tape plain. Qs. Close the corrugated box flaps and seal them using BOPP tape


In Treatment of Bacterial infections

Amoxycillin- Clavulanate for Injection contains two different medicines, Amoxycillin and

Clavulanic Acid, that work together to kill the bacteria that cause infections. Amoxycillin

works by stopping the growth of bacteria. Clavulanic Acid reduces resistance and

enhances the activity of Amoxycillin against bacteria.

This combination medicine can be used to treat many different bacterial infections

such as ear, sinus, throat, lung, urinary tract, skin, teeth, joints, and bones.

It usually makes you feel better within a few days, but you should continue taking

it as prescribed even when you feel better to make sure that all bacteria are killed

and do not become resistant.



Most side effects do not require any medical attention and disappear as your body adjusts to the medicine. Consult your doctor if they persist or if you’re worried about them

Common side effects of AMOXYCILLIN- CLAVULANATE


  • Vomiting
  • Nausea
  • Diarrhea



Amoxycillin- Clavulanate for Injection is a combination of two medicines:
Amoxycillin and Clavulanic Acid. Amoxycillin is an antibiotic.
It works by preventing the formation of the bacterial protective covering which
is essential for the survival of bacteria. Clavulanic Acid is a beta-lactamase inhibitor
that reduces resistance and enhances the activity of Amoxycillin against bacteria.