Biofield Pharma Private Limited

Brand Name: FORLUBE
Dosage Form: Ophthalmic solution
Strength: Sodium Carboxymethylcellulose IP – 0.5% w/v
Volume: 10 mL
Therapeutic Class: Artificial tear / Lubricant

• Sodium Carboxymethylcellulose – 5 mg

• Sterile aqueous vehicle – q.s.

• Preservative (if applicable)

• Acts as a viscous lubricant

• Forms a protective film over the cornea and conjunctiva

• Provides relief from dryness, irritation, and eye fatigue

• Dry eye syndrome

• Eye irritation due to environmental factors (dust, wind, screen use)

• Post-operative lubrication

• Contact lens-induced dryness

• 1–2 drops in affected eye(s) 3–6 times daily or as needed

• Wash hands before use

• Avoid touching dropper tip to eyes

• Hypersensitivity to Sodium Carboxymethylcellulose or any component

• For ophthalmic use only

• Avoid contamination of dropper tip

• Discontinue if severe irritation occurs

• Mild transient stinging or burning

• Rare: temporary blurred vision

• Store below 25°C

• Protect from light

• Keep bottle tightly closed

• Discard after 4 weeks of opening

FORLUBE is a safe and effective artificial tear that relieves dryness, irritation, and discomfort by lubricating and protecting the ocular surface. It is suitable for daily use and post-surgical eye care.

Additional Information:

• Production Capacity: Fully automated, ISO & USFDA-compliant 600,000 Sq. ft. plant with zero liquid & gas discharge facility
• Delivery Time: 45-60 DAYS
• Packaging Details: Our packaging is designed to ensure maximum product safety, stability, and market appeal. We utilize high-quality raw materials (RM) and USFDA-approved packaging components, making our products ideal for export and third-party manufacturing. Key Features of Our Packaging: ✅ Attractive & Market-Differentiating Designs: Our products come with customizable branding and change parts, allowing businesses to create a distinct identity in the pharma market. ✅ Pharmaceutical-Grade Materials: We use high-density PET bottles, tamper-evident caps, and premium blister foils to maintain product integrity. ✅ Advanced Protection: Our packaging is moisture-resistant, UV-protected, and oxidation-resistant, ensuring longer shelf life and stability. ✅ High-Precision Batch Coding & Labeling: We use laser batch coding, holographic labels, and serialized QR codes for authenticity and traceability. ✅ International Standards for Export: All our packaging materials meet USFDA, EUGMP, and WHO-GMP regulations, ensuring global compliance. Our packaging solutions help PCD Pharma companies, third-party manufacturers, and exporters differentiate their products in highly competitive markets while maintaining the highest pharmaceutical standards.

Generic Name: Hydroxypropylmethylcellulose (HPMC)
Brand Name: TEARGRIP
Strength: 0.3% w/v
Dosage Form: Ophthalmic solution (eye drops)
Therapeutic Class: Ocular lubricant / Artificial tears

TEARGRIP contains Hydroxypropylmethylcellulose (HPMC) 0.3% w/v, a lubricating polymer used to relieve dryness and irritation of the eyes. It acts as an artificial tear substitute by forming a protective film over the cornea.

Each 1 mL contains:

• Hydroxypropylmethylcellulose (HPMC) – 3 mg (0.3% w/v)

• Sterile aqueous base – q.s.

• May contain suitable preservative (e.g., benzalkonium chloride) unless preservative-free formulation

Hydroxypropylmethylcellulose increases tear viscosity and stabilizes the tear film. It:

• Lubricates the ocular surface

• Reduces friction during blinking

• Protects against irritation

• Helps maintain moisture on the cornea

• Dry eye syndrome

• Eye irritation due to dust, smoke, wind, or prolonged screen exposure

• Burning or discomfort after eye surgery (as advised by physician)

• Contact lens–related dryness (if compatible)

• Instill 1–2 drops into the affected eye(s) 3–4 times daily or as directed by a physician.

• Wash hands before use.

• Avoid touching the dropper tip to prevent contamination.

• Close eyes gently after instillation.

• Known hypersensitivity to Hydroxypropylmethylcellulose or any component of the formulation.

• Remove contact lenses before application unless product is labeled lens-compatible.

• Wait at least 10–15 minutes before using other ophthalmic medications.

• Discontinue use if irritation persists or worsens.

• Use within 4 weeks of opening (unless otherwise specified).

Generally well tolerated. Possible mild effects:

• Temporary blurred vision

• Mild stinging or irritation

• Eye redness (rare)

• Store below 25°C

• Protect from light

• Keep tightly closed

• Keep out of reach of children

Available in sterile dropper bottles (e.g., 10 mL).

Hydroxypropylmethylcellulose is a semi-synthetic polymer derived from cellulose. It enhances tear film stability and provides prolonged ocular surface contact time compared to simple saline solutions.

Additional Information:

• Production Capacity: Fully automated, ISO & USFDA-compliant 600,000 Sq. ft. plant with zero liquid & gas discharge facility
• Delivery Time: 45-60 DAYS
• Packaging Details: Our packaging is designed to ensure maximum product safety, stability, and market appeal. We utilize high-quality raw materials (RM) and USFDA-approved packaging components, making our products ideal for export and third-party manufacturing. Key Features of Our Packaging: ✅ Attractive & Market-Differentiating Designs: Our products come with customizable branding and change parts, allowing businesses to create a distinct identity in the pharma market. ✅ Pharmaceutical-Grade Materials: We use high-density PET bottles, tamper-evident caps, and premium blister foils to maintain product integrity. ✅ Advanced Protection: Our packaging is moisture-resistant, UV-protected, and oxidation-resistant, ensuring longer shelf life and stability. ✅ High-Precision Batch Coding & Labeling: We use laser batch coding, holographic labels, and serialized QR codes for authenticity and traceability. ✅ International Standards for Export: All our packaging materials meet USFDA, EUGMP, and WHO-GMP regulations, ensuring global compliance. Our packaging solutions help PCD Pharma companies, third-party manufacturers, and exporters differentiate their products in highly competitive markets while maintaining the highest pharmaceutical standards.

Generic Name: Moxifloxacin
Brand Name: MAXIWOK
Strength: 0.5% w/v
Dosage Form: Sterile Ophthalmic Solution
Therapeutic Class: Fluoroquinolone Antibiotic (Ophthalmic)

Each 1 mL contains:

• Moxifloxacin Hydrochloride equivalent to Moxifloxacin 5 mg (0.5% w/v)

• Sterile aqueous vehicle – q.s.

• (May be preservative-free depending on formulation)

Moxifloxacin is a fourth-generation fluoroquinolone antibiotic. It works by:

• Inhibiting bacterial DNA gyrase (topoisomerase II)

• Inhibiting topoisomerase IV

This prevents bacterial DNA replication, transcription, and repair, leading to bacterial cell death.

Effective against a broad range of:

• Gram-positive bacteria (e.g., Staphylococcus, Streptococcus)

• Gram-negative bacteria (e.g., Haemophilus, Pseudomonas)

• Some atypical organisms

• Bacterial conjunctivitis

• Blepharitis

• Corneal ulcers (as prescribed)

• Post-operative ocular infection prophylaxis

For bacterial conjunctivitis:

• Instill 1 drop into affected eye(s) 3 times daily for 7 days
  (Or as directed by physician)

For corneal ulcer:

• As per ophthalmologist’s recommendation (more frequent dosing may be required)

• Hypersensitivity to Moxifloxacin or other fluoroquinolones.

• For topical ophthalmic use only.

• Do not touch dropper tip to any surface.

• Discontinue if allergic reaction occurs.

• Remove contact lenses before instillation.

• Not effective for viral or fungal eye infections.

Common:

• Mild burning or stinging

• Eye irritation

• Dry eyes

Rare:

• Hypersensitivity reactions

• Swelling or redness

Minimal systemic absorption; significant drug interactions are unlikely.

• Store below 25°C

• Protect from light

• Do not freeze

• Keep bottle tightly closed

Available in sterile ophthalmic dropper bottles (e.g., 5 mL, 10 mL).

Moxifloxacin has enhanced activity against resistant Gram-positive organisms compared to earlier fluoroquinolones. Its preservative-free formulations reduce ocular irritation risk.

Additional Information:

• Production Capacity: Fully automated, ISO & USFDA-compliant 600,000 Sq. ft. plant with zero liquid & gas discharge facility
• Delivery Time: 45-60 DAYS
• Packaging Details: Our packaging is designed to ensure maximum product safety, stability, and market appeal. We utilize high-quality raw materials (RM) and USFDA-approved packaging components, making our products ideal for export and third-party manufacturing. Key Features of Our Packaging: ✅ Attractive & Market-Differentiating Designs: Our products come with customizable branding and change parts, allowing businesses to create a distinct identity in the pharma market. ✅ Pharmaceutical-Grade Materials: We use high-density PET bottles, tamper-evident caps, and premium blister foils to maintain product integrity. ✅ Advanced Protection: Our packaging is moisture-resistant, UV-protected, and oxidation-resistant, ensuring longer shelf life and stability. ✅ High-Precision Batch Coding & Labeling: We use laser batch coding, holographic labels, and serialized QR codes for authenticity and traceability. ✅ International Standards for Export: All our packaging materials meet USFDA, EUGMP, and WHO-GMP regulations, ensuring global compliance. Our packaging solutions help PCD Pharma companies, third-party manufacturers, and exporters differentiate their products in highly competitive markets while maintaining the highest pharmaceutical standards.

MAXIWOK KT – Moxifloxacin 0.5% & Ketorolac 0.5% Eye Drops

Brand Name: MAXIWOK KT
Dosage Form: Sterile Ophthalmic Solution
Strength:

• Moxifloxacin 0.5% w/v

• Ketorolac Tromethamine 0.5% w/v
  Therapeutic Class: Antibiotic + NSAID (Ophthalmic)

MAXIWOK KT is a fixed-dose ophthalmic combination used for treating bacterial eye infections accompanied by inflammation and pain, particularly in post-operative eye conditions such as cataract surgery.

It contains:

• Moxifloxacin – a broad-spectrum fourth-generation fluoroquinolone antibiotic

• Ketorolac tromethamine – a non-steroidal anti-inflammatory drug (NSAID)

This combination provides dual benefits:

• Eliminates infection

• Reduces inflammation, redness, and pain

Each 1 mL contains:

• Moxifloxacin Hydrochloride equivalent to Moxifloxacin – 5 mg (0.5% w/v)

• Ketorolac Tromethamine – 5 mg (0.5% w/v)

• Sterile aqueous vehicle – q.s.

• Suitable buffers and stabilizers

• Preservative (if applicable)

• Inhibits DNA gyrase (Topoisomerase II)

• Inhibits Topoisomerase IV

• Prevents bacterial DNA replication

• Produces bactericidal action

Effective against Gram-positive and Gram-negative organisms.

• Inhibits cyclooxygenase (COX-1 and COX-2)

• Reduces prostaglandin synthesis

• Decreases inflammation, pain, redness, and swelling

• Bacterial conjunctivitis with inflammation

• Post-operative ocular inflammation

• Prevention of infection after eye surgery

• Corneal infections with inflammatory response

• Ocular pain associated with bacterial infection

Dose:
1 drop in affected eye(s) 3–4 times daily for 5–7 days or as prescribed.

Instructions:

• Wash hands before use

• Avoid touching dropper tip

• Close eyes gently after instillation

• Maintain 5–10 minute gap between other eye drops

• Hypersensitivity to fluoroquinolones

• Hypersensitivity to NSAIDs

• Allergy to any component of the formulation

• For ophthalmic use only

• Do not inject

• Avoid contact lenses during treatment

• Prolonged NSAID use may delay corneal healing

• Discontinue if severe irritation occurs

Common:

• Mild burning or stinging

• Temporary blurred vision

• Redness

• Irritation

Rare:

• Allergic reaction

• Corneal complications (with prolonged use)

• Store below 25°C

• Protect from light

• Do not freeze

• Discard 4 weeks after opening

• Treats infection and inflammation together

• Improves patient compliance

• Reduces need for multiple medications

• Useful in post-surgical eye care

Additional Information:

• Production Capacity: Fully automated, ISO & USFDA-compliant 600,000 Sq. ft. plant with zero liquid & gas discharge facility
• Delivery Time: 45-60 DAYS
• Packaging Details: Our packaging is designed to ensure maximum product safety, stability, and market appeal. We utilize high-quality raw materials (RM) and USFDA-approved packaging components, making our products ideal for export and third-party manufacturing. Key Features of Our Packaging: ✅ Attractive & Market-Differentiating Designs: Our products come with customizable branding and change parts, allowing businesses to create a distinct identity in the pharma market. ✅ Pharmaceutical-Grade Materials: We use high-density PET bottles, tamper-evident caps, and premium blister foils to maintain product integrity. ✅ Advanced Protection: Our packaging is moisture-resistant, UV-protected, and oxidation-resistant, ensuring longer shelf life and stability. ✅ High-Precision Batch Coding & Labeling: We use laser batch coding, holographic labels, and serialized QR codes for authenticity and traceability. ✅ International Standards for Export: All our packaging materials meet USFDA, EUGMP, and WHO-GMP regulations, ensuring global compliance. Our packaging solutions help PCD Pharma companies, third-party manufacturers, and exporters differentiate their products in highly competitive markets while maintaining the highest pharmaceutical standards.

Brand Name: MAXIWOK-P
Dosage Form: Sterile Ophthalmic/Otic Solution
Strength:

• Moxifloxacin HCl – 0.5% w/v

• Prednisolone Acetate – 1% w/v
  Volume: 5 mL
  Therapeutic Class: Antibiotic + Corticosteroid

• Moxifloxacin HCl – 5 mg

• Prednisolone Acetate – 10 mg

• Sterile aqueous vehicle, buffers, stabilizers, preservative (if applicable)

• Moxifloxacin: Bactericidal via inhibition of DNA gyrase & Topoisomerase IV

• Prednisolone: Suppresses inflammation by inhibiting prostaglandins and cytokines

• Bacterial conjunctivitis, keratitis

• Otitis externa

• Post-operative ocular or ear inflammation

• Corneal or ear infections with pain/redness

• Eyes: 1–2 drops every 8 hours

• Ears: 3–4 drops 3 times daily

• Duration: 7–10 days or as prescribed

Instructions: Wash hands, avoid touching dropper, close eyes or tilt ear after instillation

• Allergy to Moxifloxacin, Prednisolone, or formulation components

• Viral, fungal, or mycobacterial infections

• Perforated eardrum (unless prescribed)

• Ophthalmic/otic use only

• Avoid contact lenses (eyes)

• Monitor intraocular pressure (eyes)

• Discontinue if irritation or allergy occurs

• Burning, stinging, blurred vision (eyes)

• Mild itching or discomfort (ears)

• Rare: secondary infection, steroid-related side effects

• Store below 25°C, protected from light

• Do not freeze

• Discard 4 weeks after opening

• Dual action: antibacterial + anti-inflammatory

• Reduces redness, swelling, and pain

• Improves compliance (single bottle therapy)

• Useful for post-operative care

Summary:
MAXIWOK-P is an effective antibiotic-steroid combination for bacterial eye/ear infections with inflammation. It treats infection while rapidly controlling redness, swelling, and pain, making it ideal for post-operative management or severe inflammatory infections.

Additional Information:

• Production Capacity: Fully automated, ISO & USFDA-compliant 600,000 Sq. ft. plant with zero liquid & gas discharge facility
• Delivery Time: 45-60 DAYS
• Packaging Details: Our packaging is designed to ensure maximum product safety, stability, and market appeal. We utilize high-quality raw materials (RM) and USFDA-approved packaging components, making our products ideal for export and third-party manufacturing. Key Features of Our Packaging: ✅ Attractive & Market-Differentiating Designs: Our products come with customizable branding and change parts, allowing businesses to create a distinct identity in the pharma market. ✅ Pharmaceutical-Grade Materials: We use high-density PET bottles, tamper-evident caps, and premium blister foils to maintain product integrity. ✅ Advanced Protection: Our packaging is moisture-resistant, UV-protected, and oxidation-resistant, ensuring longer shelf life and stability. ✅ High-Precision Batch Coding & Labeling: We use laser batch coding, holographic labels, and serialized QR codes for authenticity and traceability. ✅ International Standards for Export: All our packaging materials meet USFDA, EUGMP, and WHO-GMP regulations, ensuring global compliance. Our packaging solutions help PCD Pharma companies, third-party manufacturers, and exporters differentiate their products in highly competitive markets while maintaining the highest pharmaceutical standards.

Brand Name: MAXIWOK D
Dosage Form: Ophthalmic solution
Strength:

• Moxifloxacin HCl – 0.5% w/v

• Dexamethasone – 0.1% w/v
  Volume: 5 mL
  Therapeutic Class: Antibiotic + Corticosteroid

• Moxifloxacin HCl – 5 mg

• Dexamethasone – 1 mg

• Sterile water, buffers, stabilizers, preservative (if applicable)

• Moxifloxacin: Bactericidal via inhibition of DNA gyrase & Topoisomerase IV

• Dexamethasone: Anti-inflammatory via suppression of prostaglandins and cytokines

• Bacterial conjunctivitis and keratitis

• Post-operative ocular inflammation

• Corneal infections with redness/swelling

• Pain and inflammation associated with bacterial infection

• 1–2 drops in affected eye(s) 3–4 times daily

• Duration: 7–10 days or as prescribed

Instructions: Wash hands, avoid dropper contact with eye, keep eyes closed for 1–2 minutes

• Allergy to Moxifloxacin or Dexamethasone

• Viral, fungal, or mycobacterial infections

• Glaucoma, corneal thinning (caution)

• Ophthalmic use only

• Avoid contact lenses during treatment

• Monitor for secondary infection or increased intraocular pressure

• Burning, stinging, blurred vision

• Eye redness or irritation

• Rare: secondary infections, steroid-related complications

• Store below 25°C, protect from light

• Do not freeze

• Discard 4 weeks after opening

• Combines antibacterial and anti-inflammatory action

• Reduces redness, swelling, and pain

• Improves compliance (single bottle therapy)

• Useful in post-operative and infective ocular care

Summary: MAXIWOK D is an effective antibiotic-steroid eye drop for treating bacterial eye infections with inflammation, providing rapid relief and convenient single-bottle therapy.

Additional Information:

• Production Capacity: Fully automated, ISO & USFDA-compliant 600,000 Sq. ft. plant with zero liquid & gas discharge facility
• Delivery Time: 45-60 DAYS
• Packaging Details: Our packaging is designed to ensure maximum product safety, stability, and market appeal. We utilize high-quality raw materials (RM) and USFDA-approved packaging components, making our products ideal for export and third-party manufacturing. Key Features of Our Packaging: ✅ Attractive & Market-Differentiating Designs: Our products come with customizable branding and change parts, allowing businesses to create a distinct identity in the pharma market. ✅ Pharmaceutical-Grade Materials: We use high-density PET bottles, tamper-evident caps, and premium blister foils to maintain product integrity. ✅ Advanced Protection: Our packaging is moisture-resistant, UV-protected, and oxidation-resistant, ensuring longer shelf life and stability. ✅ High-Precision Batch Coding & Labeling: We use laser batch coding, holographic labels, and serialized QR codes for authenticity and traceability. ✅ International Standards for Export: All our packaging materials meet USFDA, EUGMP, and WHO-GMP regulations, ensuring global compliance. Our packaging solutions help PCD Pharma companies, third-party manufacturers, and exporters differentiate their products in highly competitive markets while maintaining the highest pharmaceutical standards.

Brand Name: MAXIWOK-IV
Dosage Form: Injectable solution
Strength:

• Moxifloxacin HCl – 400 mg per vial

• Mannitol 5% w/v – diluent/tonicity agent
  Therapeutic Class: Fluoroquinolone antibiotic (IV)

• Moxifloxacin Hydrochloride IP equivalent to 400 mg Moxifloxacin

• Mannitol 5% w/v as isotonic diluent

• Water for injection q.s.

• Moxifloxacin: Bactericidal by inhibiting DNA gyrase & topoisomerase IV

• Mannitol: Maintains isotonicity; no antibacterial action

• Severe bacterial infections: pneumonia, skin & soft tissue, intra-abdominal, urinary tract

• Post-operative infections

• Patients unable to take oral antibiotics

• Adults: 400 mg IV once daily

• Infusion: Dilute in 250 mL compatible IV fluid; infuse over 60 minutes

• Do not administer as bolus

• Gram-positive: Staph. aureus, Strep. pneumoniae

• Gram-negative: E. coli, Pseudomonas, Klebsiella

• Hypersensitivity to fluoroquinolones

• History of tendon disorders

• QT prolongation

• Severe hepatic impairment (caution)

• Monitor renal and hepatic function

• Avoid in patients with cardiac arrhythmias

• Hydrate adequately

• Use caution in elderly

• Common: nausea, vomiting, headache, infusion-site pain

• Rare: tendon rupture, QT prolongation, severe allergic reactions

• Store at 2–25°C

• Protect from light

• Do not freeze

• Use immediately after reconstitution

MAXIWOK-IV is a broad-spectrum IV antibiotic providing rapid systemic bactericidal action. Mannitol ensures safe IV infusion. It is ideal for severe infections requiring parenteral therapy with once-daily dosing.

Additional Information:

• Production Capacity: Fully automated, ISO & USFDA-compliant 600,000 Sq. ft. plant with zero liquid & gas discharge facility
• Delivery Time: 45-60 DAYS
• Packaging Details: Our packaging is designed to ensure maximum product safety, stability, and market appeal. We utilize high-quality raw materials (RM) and USFDA-approved packaging components, making our products ideal for export and third-party manufacturing. Key Features of Our Packaging: ✅ Attractive & Market-Differentiating Designs: Our products come with customizable branding and change parts, allowing businesses to create a distinct identity in the pharma market. ✅ Pharmaceutical-Grade Materials: We use high-density PET bottles, tamper-evident caps, and premium blister foils to maintain product integrity. ✅ Advanced Protection: Our packaging is moisture-resistant, UV-protected, and oxidation-resistant, ensuring longer shelf life and stability. ✅ High-Precision Batch Coding & Labeling: We use laser batch coding, holographic labels, and serialized QR codes for authenticity and traceability. ✅ International Standards for Export: All our packaging materials meet USFDA, EUGMP, and WHO-GMP regulations, ensuring global compliance. Our packaging solutions help PCD Pharma companies, third-party manufacturers, and exporters differentiate their products in highly competitive markets while maintaining the highest pharmaceutical standards.

Brand Name: TOBALEM
Dosage Form: Ophthalmic solution
Strength: Tobramycin 0.3% w/v
Volume: 5 mL
Class: Aminoglycoside antibiotic

• Tobramycin 3 mg

• Sterile water q.s., preservative (if any)

• Bactericidal: inhibits protein synthesis by binding 30S ribosomal subunit

• Effective mainly against Gram-negative bacteria

• Bacterial conjunctivitis

• Keratitis (superficial corneal infection)

• Blepharitis

• Post-operative prophylaxis

• 1–2 drops in affected eye(s) every 4 hours

• Severe infections: every 2 hours during waking hours

• Duration: 7–10 days

Instructions: Wash hands, avoid touching dropper tip, remove contact lenses before use

• Allergy to Tobramycin or aminoglycosides

• Fungal, viral, or mycobacterial eye infections

• Ophthalmic use only

• Prolonged use may lead to resistance

• Caution in patients with renal impairment if systemic absorption

• Mild stinging, burning, or blurred vision

• Rare: redness, itching, allergic reactions

• Store below 25°C, protect from light

• Discard 4 weeks after opening

TOBALEM is a topical antibiotic for bacterial eye infections, offering rapid bactericidal action, safe post-operative use, and minimal systemic absorption.

Additional Information:

• Production Capacity: Fully automated, ISO & USFDA-compliant 600,000 Sq. ft. plant with zero liquid & gas discharge facility
• Delivery Time: 45-60 DAYS
• Packaging Details: Our packaging is designed to ensure maximum product safety, stability, and market appeal. We utilize high-quality raw materials (RM) and USFDA-approved packaging components, making our products ideal for export and third-party manufacturing. Key Features of Our Packaging: ✅ Attractive & Market-Differentiating Designs: Our products come with customizable branding and change parts, allowing businesses to create a distinct identity in the pharma market. ✅ Pharmaceutical-Grade Materials: We use high-density PET bottles, tamper-evident caps, and premium blister foils to maintain product integrity. ✅ Advanced Protection: Our packaging is moisture-resistant, UV-protected, and oxidation-resistant, ensuring longer shelf life and stability. ✅ High-Precision Batch Coding & Labeling: We use laser batch coding, holographic labels, and serialized QR codes for authenticity and traceability. ✅ International Standards for Export: All our packaging materials meet USFDA, EUGMP, and WHO-GMP regulations, ensuring global compliance. Our packaging solutions help PCD Pharma companies, third-party manufacturers, and exporters differentiate their products in highly competitive markets while maintaining the highest pharmaceutical standards.